A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

Hoffmann-La Roche539 enrolled

Overview

This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

539

Conditions

Kidney Transplantation

Interventions

CorticosteroidsDRUG

As prescribed

NeoralDRUG

Low dose (target trough level 50-100ng/mL)

NeoralDRUG

Standard dose (target trough level 150-300ng/mL)

Zenapax

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients greater than 18 years of age * recipients of primary kidney transplant * single-organ recipients (kidney only) Exclusion Criteria: * previous treatment with Zenapax * history of malignancy (except localized skin cancer)

Locations (36)

Unnamed facility

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Renal function (as measured by GFR)

Time frame: 12 months post-transplant

Secondary Outcomes

Patient and graft survival \n

Time frame: 12 months post-transplant

Proportion of patients with biopsy-proven rejection; treatment failure.

Time frame: 6 and 12 months post-transplant

AEs, OIs, malignancies, deaths

Time frame: Throughout study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.