Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Kidney Transplantation
Interventions:	Drug: mycophenolate mofetil [CellCept] Drug: Corticosteroids Drug: Calcineurin inhibitors Drug: Sirolimus

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Participant Flow: Overall Study

	Mycophenolate Mofetil + Sirolimus	Mycophenolate Mofetil + Cyclosporine or Tacrolimus
STARTED	151	154
Safety Population	148	153
Intent-to-Treat (ITT) Population	148	151
COMPLETED	121	115
NOT COMPLETED	30	39

Baseline Characteristics

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Reporting Groups

	Description
Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Total	Total of all reporting groups

Baseline Measures

	Mycophenolate Mofetil + Sirolimus	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Total
Number of Participants [units: participants]	148	151	299
Age ^[1] [units: years] Mean ± Standard Deviation	48.7 ± 12.90	48.7 ± 12.70	48.7 ± 12.80
Gender ^[1] [units: participants]
Female	55	55	110
Male	93	96	189

[1]	Intent-to-treat population

Outcome Measures

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1. Primary:

Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 [ Time Frame: baseline to 12 months ]

Measure Type	Primary
Measure Title	Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12
Measure Description	The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.
Time Frame	baseline to 12 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 12: MMF+sirolimus = 120, MMF+CNI = 111.

Reporting Groups

	Description
Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Measured Values

	Mycophenolate Mofetil + Sirolimus	Mycophenolate Mofetil + Cyclosporine or Tacrolimus
Number of Participants Analyzed [units: participants]	148	151
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 [units: percent change] Mean ± Standard Deviation
Baseline	59.5 ± 23.86	58.8 ± 26.06
Mean Percent Change from Baseline at Month 12	24.4 ± 70.00	5.2 ± 56.33

Statistical Analysis 1 for Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.012
Median Difference (Net) ^[4]	18.7
95% Confidence Interval	( 4.2 to 33.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The primary analysis tested the null hypothesis that mean percent change from baseline to 12 months for Group 1 (mycophenolate mofetil + sirolimus) was equal to that for Group 2 (mycophenolate mofetil + cyclosporine or tacrolimus) based on the intent-to-treat population.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) as factors and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

2. Secondary:

Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24 [ Time Frame: Baseline to 24 months ]

Measure Type	Secondary
Measure Title	Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24
Measure Description	A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.
Time Frame	Baseline to 24 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 24: MMF+sirolimus = 115, MMF+CNI = 105.

Reporting Groups

	Description
Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Measured Values

	Mycophenolate Mofetil + Sirolimus	Mycophenolate Mofetil + Cyclosporine or Tacrolimus
Number of Participants Analyzed [units: participants]	148	151
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24 [units: percent change] Mean ± Standard Deviation
Baseline	59.5 ± 23.86	58.8 ± 26.06
Percent Change from Baseline at Month 24	8.6 ± 55.32	3.4 ± 67.28

Statistical Analysis 1 for Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.543
Mean Difference (Net) ^[4]	4.3
95% Confidence Interval	( -9.6 to 18.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) type as factors and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 [ Time Frame: baseline, 6, 12, and 24 months ]

Measure Type	Secondary
Measure Title	Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24
Measure Description	Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization. percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.
Time Frame	baseline, 6, 12, and 24 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Reporting Groups

	Description
Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Measured Values

	Mycophenolate Mofetil + Sirolimus	Mycophenolate Mofetil + Cyclosporine or Tacrolimus
Number of Participants Analyzed [units: participants]	148	151
Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 [units: percent change] Mean ± Standard Deviation
Baseline	121.1 ± 29.96	124.4 ± 37.87
Percent Change from Baseline at Month 6	-3.7 ± 18.78	6.6 ± 34.61
Percent Change from Baseline at Month 12	6.0 ± 57.81	20.4 ± 92.81
Percent Change from Baseline at Month 24	6.1 ± 59.84	30.8 ± 114.23

Statistical Analysis 1 for Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.003
Median Difference (Net) ^[4]	-10.8
95% Confidence Interval	( -17.9 to -3.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	6 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.108
Mean Difference (Net) ^[4]	-16.0
95% Confidence Interval	( -35.4 to 3.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	12 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.039
Mean Difference (Net) ^[4]	-24.4
95% Confidence Interval	( -47.7 to -1.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	24 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

4. Secondary:

Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 [ Time Frame: baseline 6, 12, and 24 months ]

Measure Type	Secondary
Measure Title	Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24
Measure Description	Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization. percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization
Time Frame	baseline 6, 12, and 24 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 129; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Reporting Groups

	Description
Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Measured Values

	Mycophenolate Mofetil + Sirolimus	Mycophenolate Mofetil + Cyclosporine or Tacrolimus
Number of Participants Analyzed [units: participants]	148	151
Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 [units: percent change] Mean ± Standard Deviation
Baseline	59.7 ± 16.85	60.5 ± 19.97
Percent Change from Baseline at Month 6	7.0 ± 19.54	-1.7 ± 17.22
Percent Change from Baseline at Month 12	4.4 ± 24.38	-2.3 ± 25.09
Percent Change from Baseline at Month 24	4.7 ± 27.58	-4.2 ± 27.66

Statistical Analysis 1 for Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Net) ^[4]	8.7
95% Confidence Interval	( 4.1 to 13.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	6 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.029
Mean Difference (Net) ^[4]	6.9
95% Confidence Interval	( 0.7 to 13.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	12 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.015
Mean Difference (Net) ^[4]	8.8
95% Confidence Interval	( 1.7 to 15.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	24 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

5. Secondary:

Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) [ Time Frame: baseline, 6, 12, and 24 months ]

Measure Type	Secondary
Measure Title	Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)
Measure Description	Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization. percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.
Time Frame	baseline, 6, 12, and 24 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 123, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Reporting Groups

	Description
Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Measured Values

	Mycophenolate Mofetil + Sirolimus	Mycophenolate Mofetil + Cyclosporine or Tacrolimus
Number of Participants Analyzed [units: participants]	148	151
Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) [units: percent change] Mean ± Standard Deviation
Baseline	71.3 ± 13.82	72.7 ± 16.2
Percent Change from Baseline at Month 6	8.3 ± 19.57	-0.5 ± 15.98
Percent Change from Baseline at Month 12	5.2 ± 25.33	-0.9 ± 23.42
Percent Change from Baseline at Month 24	6.5 ± 28.43	-1.8 ± 27.31

Statistical Analysis 1 for Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Net) ^[4]	8.5
95% Confidence Interval	( 4.2 to 12.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	6 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.059
Mean Difference (Net) ^[4]	5.8
95% Confidence Interval	( -0.2 to 11.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	12 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.036
Mean Difference (Net) ^[4]	7.5
95% Confidence Interval	( 0.5 to 14.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	24 months
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.
[4]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00121810 History of Changes
Other Study ID Numbers:	ML17140
Study First Received:	July 15, 2005
Results First Received:	November 18, 2009
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration