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

Kidney Transplantation Clinical Trial

Official title:

A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048152
• Other study ID #: M67005
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2002
• Last updated: November 1, 2016
• Start date: December 2000
• Est. completion date: March 2006

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 539
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Corticosteroids
As prescribed
• Neoral
Low dose (target trough level 50-100ng/mL)
• Neoral
Standard dose (target trough level 150-300ng/mL)
• Zenapax
2mg/kg iv first dose, then 1mg/kg every 2 weeks
• mycophenolate mofetil [CellCept]
1g po bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Mexico,  Norway,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function (as measured by GFR)		12 months post-transplant	No
Secondary	Patient and graft survival \n		12 months post-transplant	No
Secondary	Proportion of patients with biopsy-proven rejection; treatment failure.		6 and 12 months post-transplant	No
Secondary	AEs, OIs, malignancies, deaths		Throughout study	No