Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penang Hospital, Malaysia
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

1. Written informed consent obtained from patient or parents/guardian.

2. Patients who are more than 6 months post transplant

3. Stable graft function i.e. serum creatinine less than 300 umol/l

4. Patients currently on a stable dose of capsule Neoral within last one month

Exclusion Criteria:

1. Multiple organ transplantation

2. Pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. Effective birth control methods are oral contraception, Norplant, surgical sterilization, Intra Uterine Device or diaphragms in conjunction with spermicidal foam and condom on the male partner.

3. Participation in any drug trial in which the patient received an investigational drug within 30 days preceding the screening phase of this study.

4. Those persons directly involved in the conduct of the study.

5. Active infection at the time of screening for enrollment into trial.

6. Acute graft rejection within the past 3 months

7. Mentally unstable or history of mental diseases

8. History of drug or alcohol abuse within the past 2 years.

9. History of non-compliance to medical regimen and patients who are unwilling or unable to comply with the protocol.

10. Decompensated liver disease

11. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study