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Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk

NCT00138970 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2005-12-01

No results posted yet for this study

Summary

To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match, receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral® (full dose), CellCept® (1.0 g bid.) and prednisolone.

Conditions

  • Renal Transplant Recipients

Interventions

DRUG

Zenapax®, CellCept® and prednisolone

DRUG

Sandimmun Neoral®, CellCept® and prednisolone

Sponsors & Collaborators

  • University of Oslo School of Pharmacy

    lead OTHER

Principal Investigators

  • Anders Hartmann, MD · Rikshospitalet, Section of Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Completion
2005-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00138970 on ClinicalTrials.gov