Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection

This study has been completed.

Study NCT00006178 Information provided by National Institutes of Health Clinical Center (CC)

First Received on August 15, 2000. Last Updated on June 16, 2010 History of Changes

Results First Received: January 14, 2010

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Condition:	Kidney Failure
Interventions:	Drug: Sirolimus Drug: Thymoglobulin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sirolimus Monotherapy	No text entered.

Participant Flow: Overall Study

	Sirolimus Monotherapy
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Sirolimus Monotherapy	No text entered.

Baseline Measures

	Sirolimus Monotherapy
Number of Participants [units: participants]	12
Age [units: participants]
<=18 years	0
Between 18 and 65 years	12
>=65 years	0
Age [units: years] Mean ± Standard Deviation	45.0 ± 12.7
Gender [units: participants]
Female	4
Male	8
Region of Enrollment [units: participants]
United States	12

Outcome Measures

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1. Primary:

Serum Creatinine Concentration [ Time Frame: 6 months after intervention ]

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2. Primary:

Serum Creatinine Concentration [ Time Frame: 12 months after intervention ]

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3. Secondary:

Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney) [ Time Frame: 6 month after intervention ]

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4. Secondary:

Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney) [ Time Frame: 12 months after intervention ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
Optimal dose of RATG remains to be determined. Whether other depleting agents are as effective as RATG is unclear.

Results Point of Contact:

Name/Title: Dr. Allan D. Kirk
Organization: National Institutes of Health
phone: N/A
e-mail: allank@intra.niddk.nih.gov

Publications:

Matas AJ, Gillingham KJ, Sutherland DE. Half-life and risk factors for kidney transplant outcome--importance of death with function. Transplantation. 1993 Apr;55(4):757-61.

Morris PJ. Renal transplantation: a quarter century of achievement. Semin Nephrol. 1997 May;17(3):188-95.

Swanson SJ, Hale DA, Mannon RB, Kleiner DE, Cendales LC, Chamberlain CE, Polly SM, Harlan DM, Kirk AD. Kidney transplantation with rabbit antithymocyte globulin induction and sirolimus monotherapy. Lancet. 2002 Nov 23;360(9346):1662-4.

Responsible Party:	Monique E. Cho, M.D./National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00006178 History of Changes
Other Study ID Numbers:	000196, 00-DK-0196
Study First Received:	August 15, 2000
Results First Received:	January 14, 2010
Last Updated:	June 16, 2010
Health Authority:	United States: Federal Government