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

NCT00374647 | Completed Phase 4

• 1 other identifier: STN INV INT
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Renal Allograft

Keywords

Renal; Kidney; Transplant

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• 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.

Interventions

mycophenolate mofetil DRUG

sirolimus DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (2)

The Christ Hospital

Cincinnati, Ohio, 45267, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid; Sirolimus

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Macrolides; Lactones

Study Officials

• Steve Woodle, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: March 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

US (2)