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Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

NCT01990118 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2013-11-21

No results posted yet for this study

Summary

The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the standard treatment Neoral® for a treatment period of 6 months in stable renal allograft transplant recipients with respect to drug levels, dosage, and acute graft rejection and other adverse events.

Conditions

  • End Stage Renal Failure

Interventions

DRUG

Neoral

Neoral® capsule containing 25mg or 100mg cyclosporine

DRUG

Gengraf® capsule containing 25mg or 100mg cyclosporine

Transplant patients who were stable on Neoral were converted to Gengraf

Sponsors & Collaborators

  • Penang Hospital, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Dr.Ong L Meng, MBBS, FRCP · Penang Hospital, Ministry of Health Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-12-31
Completion
2006-05-31

Countries

  • Malaysia

Study Locations

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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 NCT01990118 on ClinicalTrials.gov