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An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil (ORANGE)

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ClinicalTrials.gov Identifier: NCT01672957
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Kidney Transplantation
Interventions Drug: Mycophenolate Mofetil
Drug: Immunosuppressive Therapy
Enrollment 128
Recruitment Details  
Pre-assignment Details If Informed Consent Form (ICF) was signed after the transplantation, it was considered as a major protocol violation and reported separately from protocol violation in Participant Flow.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.
Period Title: Overall Study
Started 128
Intent-to-treat (ITT) Population 123 [1]
Completed 73
Not Completed 55
Reason Not Completed
Protocol Violation             48
Death             2
ICF Signed After Transplantation             5
[1]
All enrolled participants who had no major protocol violation.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Baseline Participants 123
Hide Baseline Analysis Population Description
ITT population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy and had no major protocol violation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants
49.60  (13.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants
Female
44
  35.8%
Male
79
  64.2%
1.Primary Outcome
Title Creatinine Clearance at 1 Month After Transplantation
Hide Description Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 107
Mean (Standard Deviation)
Unit of Measure: mL/min
65.82  (18.32)
2.Primary Outcome
Title Creatinine Clearance at Month 6 After Transplantation
Hide Description Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 76
Mean (Standard Deviation)
Unit of Measure: mL/min
73.38  (19.43)
3.Primary Outcome
Title Creatinine Clearance at Month 12 After Transplantation
Hide Description Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: mL/min
69.69  (21.05)
4.Primary Outcome
Title Glomerular Filtration Rate (GFR) at Month 1 After Transplantation
Hide Description GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure.
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 118
Mean (Standard Deviation)
Unit of Measure: mL/min
53.54  (33.43)
5.Primary Outcome
Title GFR at Month 6 After Transplantation
Hide Description GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 83
Mean (Standard Deviation)
Unit of Measure: mL/min
56.78  (15.36)
6.Primary Outcome
Title GFR at Month 12 After Transplantation
Hide Description GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 65
Mean (Standard Deviation)
Unit of Measure: mL/min
58.03  (16.29)
7.Secondary Outcome
Title Mean Dose of Mycophenolate Mofetil
Hide Description [Not Specified]
Time Frame Baseline, Months 1, 6, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 121
Mean (Standard Deviation)
Unit of Measure: milligrams (mg)
Baseline (n=121) 2033.06  (357.86)
Month 1 (n=119) 1718.49  (543.21)
Month 6 (n=88) 1457.39  (754.51)
Month 12 (n=69) 1539.86  (669.21)
8.Secondary Outcome
Title Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
Hide Description Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.
Time Frame Baseline, Months 1, 6, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: percentage of participants
1 Other agent: at baseline (n=121) 0.8
1 Other agent: at Month 1 (n=119) 0.8
1 Other agent: at Month 6 (n=86) 2.3
1 Other agent: at Month 12 (n=69) 7.2
2 Other agents: at baseline (n=121) 90.9
2 Other agents: at Month 1 (n=119) 99.2
2 Other agents: at Month 6 (n=86) 97.7
2 Other agents: at Month 12 (n=69) 92.8
3 Other agents: at baseline (n=121) 8.3
3 Other agents: at Month 1 (n=119) 0
3 Other agents: at Month 6 (n=86) 0
3 Other agents: at Month 12 (n=69) 0
9.Secondary Outcome
Title Percentage of Participants With Acute Rejection
Hide Description Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.
Time Frame Baseline to Month 1, Months 2 to 6, Months 7 to 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 127
Measure Type: Number
Unit of Measure: percentage of participants
Baseline to Month 1 (n=127) 16.5
Months 2 to 6 (n=124) 0.8
Months 7 to 12 (n=111) 0.9
10.Secondary Outcome
Title Percentage of Participants With Graft Survival
Hide Description Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation.
Time Frame Months 1, 6, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description:
Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
Overall Number of Participants Analyzed 127
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 (n=127) 100
Month 6 (n=123) 99.2
Month 12 (n=111) 98.4
Time Frame From Baseline up to Month 12
Adverse Event Reporting Description Safety population.
 
Arm/Group Title Renal Transplant Participants
Hide Arm/Group Description Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
All-Cause Mortality
Renal Transplant Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Renal Transplant Participants
Affected / at Risk (%)
Total   33/128 (25.78%) 
Cardiac disorders   
Acute myocardial infarction * 1  1/128 (0.78%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/128 (0.78%) 
General disorders   
Sudden death * 1  1/128 (0.78%) 
Immune system disorders   
Kidney transplant rejection * 1  4/128 (3.13%) 
Transplant rejection * 1  14/128 (10.94%) 
Infections and infestations   
Cystitis * 1  1/128 (0.78%) 
Influenza * 1  1/128 (0.78%) 
Pneumonia * 1  3/128 (2.34%) 
Postoperative abscess * 1  1/128 (0.78%) 
Urinary tract infection * 1  1/128 (0.78%) 
Injury, poisoning and procedural complications   
Complications of transplanted kidney * 1  1/128 (0.78%) 
Perirenal haematoma * 1  1/128 (0.78%) 
Post procedural haemorrhage * 1  2/128 (1.56%) 
Ureteric anastomosis complication * 1  2/128 (1.56%) 
Investigations   
Blood creatinine increased * 1  1/128 (0.78%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/128 (0.78%) 
Renal and urinary disorders   
Pyelocaliectasis * 1  2/128 (1.56%) 
Tubulointerstitial nephritis * 1  1/128 (0.78%) 
Ureteral disorder * 1  1/128 (0.78%) 
Ureterolithiasis * 1  1/128 (0.78%) 
Reproductive system and breast disorders   
Varicocele * 1  1/128 (0.78%) 
Respiratory, thoracic and mediastinal disorders   
Respiration abnormal * 1  1/128 (0.78%) 
Vascular disorders   
Haematoma * 1  2/128 (1.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Renal Transplant Participants
Affected / at Risk (%)
Total   51/128 (39.84%) 
Blood and lymphatic system disorders   
Anemia * 1  13/128 (10.16%) 
Gastrointestinal disorders   
Diarrhoea * 1  19/128 (14.84%) 
Renal and urinary disorders   
Hyperuricaemia * 1  7/128 (5.47%) 
Urinary tract infection * 1  24/128 (18.75%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory infection * 1  10/128 (7.81%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
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 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01672957     History of Changes
Other Study ID Numbers: ML27844
First Submitted: August 22, 2012
First Posted: August 27, 2012
Results First Submitted: August 16, 2016
Results First Posted: October 11, 2016
Last Update Posted: October 11, 2016