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Tacrolimus to Sirolimus Conversion for Delayed Graft Function

NCT00931255 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-03-31

Study results available
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Summary

The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function (DGF)and slow graft function (SGF) in improving graft function and delaying chronic allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will improve graft function and decrease the progression of graft fibrosis.

Conditions

  • Kidney Transplant
  • Delayed Graft Function

Interventions

DRUG

Tacrolimus

3-10 mg, PO, BID based on 12 hour trough on serum blood levels, adjusted according to protocol

DRUG

Sirolimus

5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Abdolreza Haririan, MD, MPH · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931255 on ClinicalTrials.gov