Trial · NCT00377637
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
NCT00377637, Phase 3, Completed, Hoffmann-La Roche; results first posted 2011-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis. Trials, record NCT00377637. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00377637
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
- NCT number
- NCT00377637
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 370 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lupus Nephritis
- Interventions
- Mycophenolate mofetil (MMF), Cyclophosphamide, Azathioprine, Placebo to Azathioprine, Placebo to Mycophenolate mofetil, Corticosteroid
- First posted
- 2006-09-18
- Last updated
- 2011-12-06
- Results first posted
- 2011-12-06
- Limitations and caveats
- For many of the Maintenance Phase Outcomes, the total number of events precluded a meaningful time to event statistical analysis, therefore, only events numbers are reported.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Induction Phase: Number of Patients Showing Treatment Response | 24 weeks | Treatment response was adjudicated by a blinded clinical endpoints committee (CEC) and defined as: a) Decrease in proteinuria, defined as a decrease in the urine protein to creatinine ratio (UPCr) to \<3 in subjects with baseline proteinuria ≥3 UPCr or a decrease in the UPCr by ≥50% in subjects with proteinuria \<3 UPCr at Baseline, and b) Stabilization of serum creatinine or improvement. UPCr were derived from the 24 hour urine collection. Patients who did not show a treatment response at Week 24 or who withdrew earlier than Week 24 were considered non-responders. |
| Primary | Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval | From the start of the Maintenance Phase to Month 36 | Treatment Failure was adjudicated by a clinical endpoints committee and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to treatment failure for each patient. The data presented are the percentage of participants who were treatment-failure free at each time interval as estimated by Kaplan-Meier. |
| Secondary | Induction Phase: Number of Participants Achieving Complete Remission | 24 weeks | Number of participants achieving complete remission as defined by return to normal serum creatinine, proteinuria ≤500 mg/24 hours and an inactive urinary sediment (absence of red blood cells, white blood cells or cellular or granular casts) after 24 weeks. |
| Secondary | Induction Phase: Change From Baseline to Week 24 in Serum Creatinine | Baseline, Week 24 | |
| Secondary | Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein | Baseline, Week 24 | 24-hour urine protein was measured at Baseline and Week 24. |
| Secondary | Induction Phase: Change From Baseline to Week 24 in Serum Albumin | Baseline, Week 24 | |
| Secondary | Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score | Baseline, 24 weeks | BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. The BILAG individual system summaries were calculated by a program supplied by ADS-Limathon (Sheffield, UK). The score at baseline was compared to the score at the 24 week endpoint for each treatment group, reported here for the renal system. |
| Secondary | Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores | Baseline and 24 weeks | The SF-36 is a 36 item quality of life questionnaire. The short-form version has eleven questions that permit the participant to rate how they feel that particular day. The SF-36 consists of eight scaled scores and two component scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score with the higher scores indicating better quality of life. |
| Secondary | Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths | From the start of the Maintenance Phase to Month 36 | Treatment Failure was adjudicated by a clinical endpoints committee (CEC) and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis (LN). |
| Secondary | Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD) | From the start of the Maintenance Phase to Month 36 | Time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), was defined as any 1 the following: death, ESRD, sustained doubling of serum creatinine, renal flare (proteinuric or nephritic), or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. ESRD is defined as progression to chronic hemodialysis or renal transplant. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Induction Phase: Number of Patients Showing Treatment Response | 24 weeks | Analysis population was intent to treat which comprised all subjects who were randomized into the study and had at least one post-baseline efficacy assessment. | participants | NUMBER |
| PRIMARY | Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval | From the start of the Maintenance Phase to Month 36 | Intent to treat analysis population which consisted of all subjects who were randomized to the maintenance phase of the study and had at least 1 maintenance efficacy assessment. | Percentage of participants | NUMBER |
| SECONDARY | Induction Phase: Number of Participants Achieving Complete Remission | 24 weeks | Analysis population was intent to treat. | participants | NUMBER |
| SECONDARY | Induction Phase: Change From Baseline to Week 24 in Serum Creatinine | Baseline, Week 24 | Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n. | µmol/L | MEAN |
| SECONDARY | Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein | Baseline, Week 24 | Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n. | mg/day | MEAN |
| SECONDARY | Induction Phase: Change From Baseline to Week 24 in Serum Albumin | Baseline, Week 24 | Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n. | g/L | MEAN |
| SECONDARY | Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score | Baseline, 24 weeks | Analysis population was intent to treat. The endpoint was defined using the last observation carried forward approach. If no post-Baseline value was available, endpoint was considered missing. | Percentage of participants | NUMBER |
| SECONDARY | Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores | Baseline and 24 weeks | This analysis population is intention to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n. | Scores on a scale | MEAN |
| SECONDARY | Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths | From the start of the Maintenance Phase to Month 36 | Maintenance Phase intent to treat population. | Deaths | NUMBER |
| SECONDARY | Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD) | From the start of the Maintenance Phase to Month 36 | Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure. | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group158
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Induction Phase: Number of Patients Showing Treatment Response | Intravenous Cyclophosphamide | Responder | 98 | participants | |
| Induction Phase: Number of Patients Showing Treatment Response | Mycophenolate Mofetil | Responder | 104 | participants | |
| Induction Phase: Number of Patients Showing Treatment Response | Intravenous Cyclophosphamide | Non-responder | 87 | participants | |
| Induction Phase: Number of Patients Showing Treatment Response | Mycophenolate Mofetil | Non-responder | 81 | participants | |
| Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval | Mycophenolate Mofetil | Start of Maintenance Phase to Month 3 | 98.2 | Percentage of participants | |
| Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval | Azathioprine | Start of Maintenance Phase to Month 3 | 97.2 | Percentage of participants | |
| Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval | Mycophenolate Mofetil | Month 3 to Month 6 | 93.7 | Percentage of participants | |
| Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval | Azathioprine | Month 3 to Month 6 | 89.3 | Percentage of participants | |
| Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval | Mycophenolate Mofetil | Month 6 to Month 9 | 89.9 | Percentage of participants | |
| Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval | Azathioprine | Month 6 to Month 9 | 86.2 | Percentage of participants |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Phase | STARTED | Induction Phase: Cyclophosphamide | 185 | |
| Induction Phase | STARTED | Induction Phase: Mycophenolate Mofetil | 185 | |
| Induction Phase | STARTED | Maintenance Phase: Mycophenolate Mofetil | 0 | |
| Induction Phase | STARTED | Maintenance Phase: Azathioprine | 0 | |
| Induction Phase | Safety Population | Induction Phase: Cyclophosphamide | 180 | |
| Induction Phase | Safety Population | Induction Phase: Mycophenolate Mofetil | 184 | |
| Induction Phase | Safety Population | Maintenance Phase: Mycophenolate Mofetil | 0 | |
| Induction Phase | Safety Population | Maintenance Phase: Azathioprine | 0 | |
| Induction Phase | COMPLETED | Induction Phase: Cyclophosphamide | 156 | |
| Induction Phase | COMPLETED | Induction Phase: Mycophenolate Mofetil | 150 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events852
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Induction Phase: Cyclophosphamide | 29 | 180 | |
| other | Nasopharyngitis | Infections and infestations | Induction Phase: Mycophenolate Mofetil | 25 | 184 | |
| other | Nasopharyngitis | Infections and infestations | Maintenance Phase: Mycophenolate Mofetil | 15 | 115 | |
| other | Nasopharyngitis | Infections and infestations | Maintenance Phase: Azathioprine | 13 | 111 | |
| other | Upper respiratory tract infection | Infections and infestations | Induction Phase: Cyclophosphamide | 28 | 180 | |
| other | Upper respiratory tract infection | Infections and infestations | Induction Phase: Mycophenolate Mofetil | 17 | 184 | |
| other | Upper respiratory tract infection | Infections and infestations | Maintenance Phase: Mycophenolate Mofetil | 41 | 115 | |
| other | Upper respiratory tract infection | Infections and infestations | Maintenance Phase: Azathioprine | 36 | 111 | |
| other | Herpes zoster | Infections and infestations | Induction Phase: Cyclophosphamide | 6 | 180 | |
| other | Herpes zoster | Infections and infestations | Induction Phase: Mycophenolate Mofetil | 14 | 184 |
1 to 10 of 852Source ClinicalTrials.gov
See all 852 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Phase: Cyclophosphamide | ||
| Total, all-cause mortality | Induction Phase: Mycophenolate Mofetil | ||
| Total, all-cause mortality | Maintenance Phase: Mycophenolate Mofetil | ||
| Total, all-cause mortality | Maintenance Phase: Azathioprine | ||
| Total, other adverse events | Induction Phase: Cyclophosphamide | 171 | 180 |
| Total, other adverse events | Induction Phase: Mycophenolate Mofetil | 177 | 184 |
| Total, other adverse events | Maintenance Phase: Mycophenolate Mofetil | 113 | 115 |
| Total, other adverse events | Maintenance Phase: Azathioprine | 108 | 111 |
| Total, serious adverse events | Induction Phase: Cyclophosphamide | 41 | 180 |
| Total, serious adverse events | Induction Phase: Mycophenolate Mofetil | 51 | 184 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mycophenolate Mofetil (MMF) vs Azathioprine (AZA): Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD) | Trial comparisons |
| Mycophenolate Mofetil vs Azathioprine: Maintenance Phase: Participants With Major Extra-renal Flare | Trial comparisons |
| Mycophenolate Mofetil vs Azathioprine: Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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