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OpenTrials
Completed

NCT Number: NCT00048152

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Corticosteroids

Drug

As prescribed

Neoral

Drug

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

Zenapax

Drug

2mg/kg iv first dose, then 1mg/kg every 2 weeks

mycophenolate mofetil [CellCept]

Drug

1g po bid

Primary outcomes

  1. Renal function (as measured by GFR)

    Time frame: 12 months post-transplant

Secondary outcomes

  1. Patient and graft survival \n

    Time frame: 12 months post-transplant

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

    Time frame: 6 and 12 months post-transplant

  3. AEs, OIs, malignancies, deaths

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Oct 25, 2002
Registry last updated
Nov 2, 2016

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.

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