Trial · NCT00038948
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
NCT00038948, Phase 3, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2010-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients. Trials, record NCT00038948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00038948
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
- NCT number
- NCT00038948
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 830 participants, actual
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Conditions
- Renal Transplantation
- Interventions
- Sirolimus, tacrolimus, Cyclosporine A
- First posted
- 2002-06-07
- Last updated
- 2010-05-14
- Results first posted
- 2010-05-14
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nankivell Glomerular Filtration Rate (GFR) | 52 weeks | Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function. |
| Secondary | First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | 52 and 104 weeks | Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Nankivell Glomerular Filtration Rate (GFR) | 52 weeks | Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR \>40 mL/min. | mL/min | MEAN |
| SECONDARY | First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | 52 and 104 weeks | Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR \>40 mL/min. | patients | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Nankivell Glomerular Filtration Rate (GFR) | SRL Conversion Strata 20.0-40.0 mL/Min | 24.56 | Standard Error 2.42 | mL/min | |
| Nankivell Glomerular Filtration Rate (GFR) | CNI Continuation Strata 20.0-40.0 mL/Min | 27.24 | Standard Error 3.71 | mL/min | |
| Nankivell Glomerular Filtration Rate (GFR) | SRL Conversion Strata >40.0 mL/Min | 59.04 | Standard Error 0.89 | mL/min | |
| Nankivell Glomerular Filtration Rate (GFR) | CNI Continuation Strata >40.0 mL/Min | 57.73 | Standard Error 1.1 | mL/min | |
| First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | SRL Conversion Strata 20.0-40.0 mL/Min | 52 weeks - Acute rejection | 4 | patients | |
| First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | CNI Continuation Strata 20.0-40.0 mL/Min | 52 weeks - Acute rejection | 0 | patients | |
| First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | SRL Conversion Strata >40.0 mL/Min | 52 weeks - Acute rejection | 8 | patients | |
| First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | CNI Continuation Strata >40.0 mL/Min | 52 weeks - Acute rejection | 3 | patients | |
| First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | SRL Conversion Strata 20.0-40.0 mL/Min | 52 weeks - Graft loss | 7 | patients | |
| First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | CNI Continuation Strata 20.0-40.0 mL/Min | 52 weeks - Graft loss | 3 | patients |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SRL Conversion in Stable Renal Transplant Recipients | 555 | |
| Overall Study | STARTED | CNI Continuation in Stable Renal Transplant Recipients | 275 | |
| Overall Study | COMPLETED | SRL Conversion in Stable Renal Transplant Recipients | 386 | |
| Overall Study | COMPLETED | CNI Continuation in Stable Renal Transplant Recipients | 198 | |
| Overall Study | NOT COMPLETED | SRL Conversion in Stable Renal Transplant Recipients | 169 | |
| Overall Study | NOT COMPLETED | CNI Continuation in Stable Renal Transplant Recipients | 77 |
Source ClinicalTrials.gov
Adverse events730
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 | Abdominal pain | General disorders | SRL Conversion in Stable Renal Transplant Recipients | 87 | 551 | |
| other | Abdominal pain | General disorders | CNI Continuation in Stable Renal Transplant Recipients | 42 | 273 | |
| other | Accidental injury | General disorders | SRL Conversion in Stable Renal Transplant Recipients | 98 | 551 | |
| other | Accidental injury | General disorders | CNI Continuation in Stable Renal Transplant Recipients | 39 | 273 | |
| other | Asthenia | General disorders | SRL Conversion in Stable Renal Transplant Recipients | 75 | 551 | |
| other | Asthenia | General disorders | CNI Continuation in Stable Renal Transplant Recipients | 30 | 273 | |
| other | Back pain | General disorders | SRL Conversion in Stable Renal Transplant Recipients | 46 | 551 | |
| other | Back pain | General disorders | CNI Continuation in Stable Renal Transplant Recipients | 37 | 273 | |
| other | Chest pain | General disorders | SRL Conversion in Stable Renal Transplant Recipients | 42 | 551 | |
| other | Chest pain | General disorders | CNI Continuation in Stable Renal Transplant Recipients | 23 | 273 |
1 to 10 of 730Source ClinicalTrials.gov
See all 730 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SRL Conversion in Stable Renal Transplant Recipients | ||
| Total, all-cause mortality | CNI Continuation in Stable Renal Transplant Recipients | ||
| Total, other adverse events | SRL Conversion in Stable Renal Transplant Recipients | 545 | 551 |
| Total, other adverse events | CNI Continuation in Stable Renal Transplant Recipients | 264 | 273 |
| Total, serious adverse events | SRL Conversion in Stable Renal Transplant Recipients | 81 | 551 |
| Total, serious adverse events | CNI Continuation in Stable Renal Transplant Recipients | 45 | 273 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22143911 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| SRL Conversion in Stable Renal Transplant Recipients vs CNI Continuation in Stable Renal Transplant Recipients: serious adverse events |
Source 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/NCT00038948
GET https://conductscience.org/api/trials/v1/NCT00038948/results?page=2