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Calcineurin Inhibitor Sparing After Kidney Transplantation

NCT01062555 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2020-12-14

Study results available
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Summary

Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney. In some patients, this toxicity is thought to be associated with loss of transplant function in those who have had their transplants for many years. The introduction of new immunosuppression medications however, has provided the opportunity to minimize or avoid CNIs, which may reduce the occurrence of toxicity to the kidney.

Conditions

  • CNI Side Effects

Interventions

DRUG

Cyclosporine & Cellcept

Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.

DRUG

Prograf & Cellcept

Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.

DRUG

Low Dose CNI (Cyclosporine or FK) and Cellcept

Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.

DRUG

Rapamune and Cellcept

Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Arthur Matas, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-01
Primary Completion
2014-04-03
Completion
2014-04-03

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01062555 on ClinicalTrials.gov