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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Kidney Failure; Graft vs Host Disease

Treatments: Drug: Tacrolimus; Drug: prednisone; Drug: Sirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195429

0468E-101535

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Sirolimus + Tacrolimus

Experimental group

Treatment:

Drug: Tacrolimus

Drug: Sirolimus

Sirolimus + Prednisone

Active Comparator group

Treatment:

Drug: prednisone

Drug: Sirolimus