Trial · NCT00533442
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
NCT00533442, Phase 2, Completed, University of Miami; results first posted 2017-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients. Trials, record NCT00533442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00533442
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
- NCT number
- NCT00533442
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 170 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Type 1 Diabetes
- Interventions
- Rapamycin, Mycophenolate Mofetil, Tacrolimus, Steroids
- First posted
- 2007-09-21
- Last updated
- 2017-07-12
- Results first posted
- 2017-07-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Specific Survival Comparisons | over 1-10 years post-transplant | Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival. |
| Secondary | Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant. | at 1-5 years post-transplant | Comparisons of renal function (eGFR, measured in mL/min/1.73 m\^2) at 12, 36, and 60 months post-transplant. |
| Secondary | Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant. | at 1-5 years post-transplant | Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-Specific Survival Comparisons | over 1-10 years post-transplant | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant. | at 1-5 years post-transplant | Number analyzed here includes all patients alive with a functioning graft that had an available measurement taken at that time | mL/min/1.73m^2 | MEAN |
| SECONDARY | Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant. | at 1-5 years post-transplant | Number analyzed here includes all patients alive with a functioning graft that had an available measurement taken at that time | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-Specific Survival Comparisons | Tacrolimus Plus MMF Plus Steroids | Biopsy-Proven Acute Rejection of the Kidney | 22 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus Rapamycin Plus Steroids | Biopsy-Proven Acute Rejection of the Kidney | 8 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus MMF Plus Steroids | Biopsy-Proven Acute Rejection of the Pancreas | 9 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus Rapamycin Plus Steroids | Biopsy-Proven Acute Rejection of the Pancreas | 1 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus MMF Plus Steroids | Death-Censored Kidney Graft Failure | 18 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus Rapamycin Plus Steroids | Death-Censored Kidney Graft Failure | 10 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus MMF Plus Steroids | Death-Censored Pancreas Graft Failure | 7 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus Rapamycin Plus Steroids | Death-Censored Pancreas Graft Failure | 2 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus MMF Plus Steroids | Death-Uncensored Graft (Kidney&Pancreas) Survival | 26 | Participants | |
| Event-Specific Survival Comparisons | Tacrolimus Plus Rapamycin Plus Steroids | Death-Uncensored Graft (Kidney&Pancreas) Survival | 25 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Allocation and Intent to Treat Analysis | STARTED | Tacrolimus Plus MMF Plus Steroids | 86 | |
| Allocation and Intent to Treat Analysis | STARTED | Tacrolimus Plus Rapamycin Plus Steroids | 84 | |
| Allocation and Intent to Treat Analysis | COMPLETED | Tacrolimus Plus MMF Plus Steroids | 86 | |
| Allocation and Intent to Treat Analysis | COMPLETED | Tacrolimus Plus Rapamycin Plus Steroids | 84 | |
| Allocation and Intent to Treat Analysis | NOT COMPLETED | Tacrolimus Plus MMF Plus Steroids | 0 | |
| Allocation and Intent to Treat Analysis | NOT COMPLETED | Tacrolimus Plus Rapamycin Plus Steroids | 0 | |
| Follow-up | STARTED | Tacrolimus Plus MMF Plus Steroids | 86 | |
| Follow-up | STARTED | Tacrolimus Plus Rapamycin Plus Steroids | 84 | |
| Follow-up | COMPLETED | Tacrolimus Plus MMF Plus Steroids | 77 | |
| Follow-up | COMPLETED | Tacrolimus Plus Rapamycin Plus Steroids | 74 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
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 | New Onset Diabetes Mellitus Type 2 after Transplant (NODAT) | Endocrine disorders | Tacrolimus Plus MMF Plus Steroids | 3 | 86 | 3 |
| other | New Onset Diabetes Mellitus Type 2 after Transplant (NODAT) | Endocrine disorders | Tacrolimus Plus Rapamycin Plus Steroids | 5 | 84 | 5 |
| serious | Infection | Infections and infestations | Tacrolimus Plus MMF Plus Steroids | 31 | 86 | 31 |
| serious | Infection | Infections and infestations | Tacrolimus Plus Rapamycin Plus Steroids | 32 | 84 | 32 |
| serious | Major Cardiovascular Event | Vascular disorders | Tacrolimus Plus MMF Plus Steroids | 15 | 86 | 15 |
| serious | Major Cardiovascular Event | Vascular disorders | Tacrolimus Plus Rapamycin Plus Steroids | 11 | 84 | 11 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tacrolimus Plus MMF Plus Steroids | 16 | 86 |
| Total, all-cause mortality | Tacrolimus Plus Rapamycin Plus Steroids | 15 | 84 |
| Total, other adverse events | Tacrolimus Plus MMF Plus Steroids | 3 | 86 |
| Total, other adverse events | Tacrolimus Plus Rapamycin Plus Steroids | 5 | 84 |
| Total, serious adverse events | Tacrolimus Plus MMF Plus Steroids | 40 | 86 |
| Total, serious adverse events | Tacrolimus Plus Rapamycin Plus Steroids | 38 | 84 |
Source ClinicalTrials.gov
Papers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tacrolimus Plus MMF Plus Steroids vs Tacrolimus Plus Rapamycin Plus Steroids: deaths from any cause | Trial comparisons |
| Tacrolimus Plus MMF Plus Steroids vs Tacrolimus Plus Rapamycin Plus Steroids: serious adverse events | 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00533442
GET https://conductscience.org/api/trials/v1/NCT00533442/results?page=2