Trial intelligence / Profile preview

Prograf vs Neoral in Hispanic Kidney Transplant Recipients

NCT00983645Phase 4

Key facts

Status
Terminated
Start
Oct 2004
Primary completion
Oct 2012
Countries
1
Sponsor
Loma Linda University
Modality
Peptides, Orthosteric Ligands
Conditions
kidney transplant rejection
01

Overview

Phase 4, randomised, open-label trial of tacrolimus + Wuzhi capsule and cyclosporine in kidney transplant rejection (2 arms), sponsored by Loma Linda University. Primary endpoint: Rejection at 6 months. Started Oct 2004; status: terminated.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Neoral

    Cyclosporine (Neoral) starting dose 3mg/kg PO BID

  • Prograf

    Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID

03

Who it enrols

Adult Hispanic patients receiving a primary cadaveric or living donor kidney transplant, excluding those with prior transplants, multi-organ transplants, history of diabetes mellitus, PRA > 20%, or cold ischemia time > 24 hours.

04

Endpoints

Primary

  • Rejection

Secondary

  • Renal Function

  • Post-transplant Diabetes Mellitus

  • Lipid Levels

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