Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374647

Enrollment

Registered

2006-09-11

Start date

2005-03-31

Completion date

2007-12-31

Last updated

2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Renal Allograft

Keywords

Renal, Kidney, Transplant

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.

Interventions

DRUGmycophenolate mofetil

DRUGsirolimus

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026