Skip to main content
OpenTrials
Completed

NCT Number: NCT00195429

A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Immune System Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • End-stage renal disease, with patients scheduled to receive a kidney transplant.
  • Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
  • Signed informed consent.

Exclusion criteria

  • Evidence of active systemic or localized major infection at the time of initial study drug administration;
  • Multiple organ transplants;
  • Any pathology or medical condition that can interfere with this protocol study proposal.

Other exclusion applies.

Treatment and study plan

Tacrolimus

Drug

sirolimus

Drug

Prednisone

Drug

Primary outcomes

  1. Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.

    Time frame: 12 months

    Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).

Secondary outcomes

  1. Creatinine Clearance Rate

    Time frame: 12 months

    Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients

Important dates

Study start
2005
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.