Trial · NCT00086346
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
NCT00086346, Phase 3, Terminated, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2009-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients. Trials, record NCT00086346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00086346
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
- NCT number
- NCT00086346
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 607 participants, actual
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Conditions
- Liver Transplantation
- Interventions
- Sirolimus (Rapamune), Cyclosporine or Tacrolimus
- First posted
- 2004-07-02
- Last updated
- 2010-04-28
- Results first posted
- 2009-09-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR) | Baseline and 12 months | GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is \>90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects. |
| Primary | Patient and Graft Survival | 12 months | Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses. |
| Secondary | Number of Patients With a Biopsy Confirmed Acute Rejection | 12 months | Overall event rate is determined as yes or no. |
| Secondary | Mean Serum Creatinine | 12 months | Observed mean values for serum creatinine. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR) | Baseline and 12 months | The intent to treat population was analyzed and consisted of all patients randomly assigned to treatment. Patients were stratified by hepatitis C status and whether or not they were receiving antimetabolite therapy at time of randomization. | mL/min | MEAN |
| SECONDARY | Number of Patients With a Biopsy Confirmed Acute Rejection | 12 months | The analysis population is the intent to treat. Any patient whose clinical rejection data was incomplete was designated as an acute rejection in the analysis. | patients | NUMBER |
| SECONDARY | Mean Serum Creatinine | 12 months | On-therapy population; consisted of patients who were still receiving study medication at the defined endpoint. | µmol/L | MEAN |
| PRIMARY | Patient and Graft Survival | 12 months | Intent to treat analysis population with stratification by antimetabolite therapy and hepatitis C status. | patients | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR) | Sirolimus (SRL) Conversion | -4.45 | Standard Error 1.12 | mL/min | |
| Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR) | Calcineurin Inhibitors (CNI) Continuation | -3.07 | Standard Error 1.36 | mL/min | |
| Number of Patients With a Biopsy Confirmed Acute Rejection | Sirolimus (SRL) Conversion | Yes | 46 | patients | |
| Number of Patients With a Biopsy Confirmed Acute Rejection | Calcineurin Inhibitors (CNI) Continuation | Yes | 13 | patients | |
| Number of Patients With a Biopsy Confirmed Acute Rejection | Sirolimus (SRL) Conversion | No | 347 | patients | |
| Number of Patients With a Biopsy Confirmed Acute Rejection | Calcineurin Inhibitors (CNI) Continuation | No | 201 | patients | |
| Mean Serum Creatinine | Sirolimus (SRL) Conversion | 119.0 | Standard Deviation 38.9 | µmol/L | |
| Mean Serum Creatinine | Calcineurin Inhibitors (CNI) Continuation | 122.4 | Standard Deviation 31.5 | µmol/L | |
| Patient and Graft Survival | Sirolimus (SRL) Conversion | Graft survival | 367 | patients | |
| Patient and Graft Survival | Calcineurin Inhibitors (CNI) Continuation | Graft survival | 202 | patients |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Sirolimus (SRL) Conversion | 393 | |
| Randomization | STARTED | Calcineurin Inhibitors (CNI) Continuation | 214 | |
| Randomization | COMPLETED | Sirolimus (SRL) Conversion | 389 | |
| Randomization | COMPLETED | Calcineurin Inhibitors (CNI) Continuation | 210 | |
| Randomization | NOT COMPLETED | Sirolimus (SRL) Conversion | 4 | |
| Randomization | NOT COMPLETED | Calcineurin Inhibitors (CNI) Continuation | 4 | |
| Patients Dosed With Test Article | STARTED | Sirolimus (SRL) Conversion | 389 | |
| Patients Dosed With Test Article | STARTED | Calcineurin Inhibitors (CNI) Continuation | 210 | |
| Patients Dosed With Test Article | COMPLETED | Sirolimus (SRL) Conversion | 249 | |
| Patients Dosed With Test Article | COMPLETED | Calcineurin Inhibitors (CNI) Continuation | 187 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events564
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 | Sirolimus (SRL) Conversion | 70 | 389 | |
| other | Abdominal pain | General disorders | Calcineurin Inhibitors (CNI) Continuation | 30 | 210 | |
| other | Accidental injury | General disorders | Sirolimus (SRL) Conversion | 67 | 389 | |
| other | Accidental injury | General disorders | Calcineurin Inhibitors (CNI) Continuation | 32 | 210 | |
| other | Asthenia | General disorders | Sirolimus (SRL) Conversion | 79 | 389 | |
| other | Asthenia | General disorders | Calcineurin Inhibitors (CNI) Continuation | 28 | 210 | |
| other | Back pain | General disorders | Sirolimus (SRL) Conversion | 42 | 389 | |
| other | Back pain | General disorders | Calcineurin Inhibitors (CNI) Continuation | 27 | 210 | |
| other | Chest pain | General disorders | Sirolimus (SRL) Conversion | 31 | 389 | |
| other | Chest pain | General disorders | Calcineurin Inhibitors (CNI) Continuation | 18 | 210 |
1 to 10 of 564Source ClinicalTrials.gov
See all 564 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sirolimus (SRL) Conversion | ||
| Total, all-cause mortality | Calcineurin Inhibitors (CNI) Continuation | ||
| Total, other adverse events | Sirolimus (SRL) Conversion | 386 | 389 |
| Total, other adverse events | Calcineurin Inhibitors (CNI) Continuation | 201 | 210 |
| Total, serious adverse events | Sirolimus (SRL) Conversion | 193 | |
| Total, serious adverse events | Calcineurin Inhibitors (CNI) Continuation | 79 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00086346
GET https://conductscience.org/api/trials/v1/NCT00086346/events?page=2