---
title: Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts
nct_id: NCT00374647
overall_status: COMPLETED
phase: PHASE4
sponsor: University of Cincinnati
study_type: INTERVENTIONAL
primary_condition: Primary Renal Allograft
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00374647.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00374647"
ct_last_update_post_date: 2021-07-15
last_seen_at: "2026-05-12T07:30:27.114Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts

**Official Title:** Open Label Randomized Single Study to Evaluate the Safety & Efficacy of Early CNI Withdrawal in Recipients of Primary Renal Allografts Maintained Long-Term on Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)

**NCT ID:** [NCT00374647](https://clinicaltrials.gov/study/NCT00374647)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 17
- **Lead Sponsor:** University of Cincinnati
- **Conditions:** Primary Renal Allograft
- **Start Date:** 2005-03
- **Completion Date:** 2007-12
- **CT.gov Last Update:** 2021-07-15

## Brief Summary

Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Male and female patients between 18 and 75 years of age.
* Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.
* Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.
* Capable of providing written informed consent.
* No known contraindications to treatment with sirolimus.

Exclusion Criteria:

* Pregnant or lactating.
* Acute rejection within 90 days prior to study randomization.
* More than one biopsy proven acute rejection episode prior to study randomization.
* Previously received or are receiving an organ transplant other than kidney.
* Receiving sirolimus prior to entry.
* Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication.
* Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection.
* History of malignancy in the past 5 years.
* Require dialysis at the time of study entry.
```

## Interventions

- **mycophenolate mofetil** (DRUG)
- **sirolimus** (DRUG)

## Primary Outcomes

- **Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.**

## Secondary Outcomes

- **Renal allograft function at 6 and 12 months.**
- **Incidence of biopsy proven acute rejection at 6 and 12 months.**
- **Time to first rejection.**
- **Total number of rejection episodes per patient.**
- **Graft loss and patient death.**
- **Incidence of treatment failure.**

## Locations (2)

- The Christ Hospital, Cincinnati, Ohio, United States
- University of Cincinnati, Cincinnati, Ohio, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the christ hospital|cincinnati|ohio|united states` — added _(2026-05-12)_
- `locations.university of cincinnati|cincinnati|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00374647.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00374647*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*