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

Kidney Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195429
• Other study ID #: 0468E-101535
• Status: Completed
• Phase: Phase 4
• Start date: August 2005
• Est. completion date: October 2007

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Graft vs Host Disease
• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Tacrolimus

• Sirolimus

• prednisone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.	Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).	12 months
Secondary	Creatinine Clearance Rate	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.	12 months