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Completed Phase 4 Interventional Results available

Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients

ClinicalTrials.gov ID: NCT00121810

Public ClinicalTrials.gov record NCT00121810. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 6:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Early Calcineurin Inhibitor Withdrawal in Recipients of Primary Renal Allografts Maintained Long-term on Mycophenolate Mofetil (MMF) (CellCept®) and Sirolimus (Rapamune®)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Study identification

NCT ID
NCT00121810
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
305 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2003 (Type not available)
Primary completion
Nov 2009 (Actual)
Completion
Nov 2009 (Actual)
Last update posted
Apr 15, 2011

2003 – 2009

United States locations

U.S. sites
36
U.S. states
24
U.S. cities
33
Facility City State ZIP Site status
Not listed Bakersfield California 93309 —
Not listed Los Angeles California 90033 —
Not listed Los Angeles California 90057 —
Not listed Palo Alto California 94304-1509 —
Not listed Riverside California 92501 —
Not listed San Diego California 92123 —
Not listed San Francisco California 94115 —
Not listed Denver Colorado 80262 —
Not listed Hartford Connecticut 06106-3316 —
Not listed Washington D.C. District of Columbia 20010-2975 —
Not listed Atlanta Georgia 30322 —
Not listed Maywood Illinois 60153 —
Not listed Indianapolis Indiana 46202-5124 —
Not listed Indianapolis Indiana 46202 —
Not listed Iowa City Iowa 52242 —
Not listed Lexington Kentucky 40536-0293 —
Not listed New Orleans Louisiana 70112 —
Not listed Baltimore Maryland 21201 —
Not listed Boston Massachusetts 02114-2696 —
Not listed Detroit Michigan 48202-2689 —
Not listed Camden New Jersey 08103 —
Not listed Livingston New Jersey 07039 —
Not listed New York New York 10029 —
Not listed New York New York 10032 —
Not listed Durham North Carolina 27710 —
Not listed Cincinnati Ohio 45267-0558 —
Not listed Portland Oregon 97201 —
Not listed Philadelphia Pennsylvania 19107 —
Not listed Charleston South Carolina 29425 —
Not listed Sioux Falls South Dakota 57105 —
Not listed Memphis Tennessee 38104 —
Not listed Nashville Tennessee 37232 —
Not listed Dallas Texas 75246 —
Not listed Galveston Texas 77555 —
Not listed San Antonio Texas 78284 —
Not listed Charlottesville Virginia 22908 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00121810, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 15, 2011 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00121810 live on ClinicalTrials.gov.

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