Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

End Stage Renal Failure Clinical Trial

Official title:

A Randomized, Multi-center, Open Label Trial to Establish the Therapeutic Equivalence Between Neoral® and Gengraf® in Stable Renal Allograft Recipients [Gengraf Conversion Study]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990118
• Other study ID #: 15.041
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2010
• Last updated: November 15, 2013
• Start date: November 2004
• Est. completion date: May 2006

Study information

• Verified date: November 2013
• Source: Penang Hospital, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

The introduction of cyclosporine (CsA) into clinical practice resulted in improvements in acute renal allograft rejection rate and graft survival in renal transplant patients. Gengraf a microemulsion formulation of CsA though granted an AB-rated equivalent to Neoral, because of concerns over the use of generic drugs in transplantation, we undertook this study to evaluate the clinical efficacy and safety of Gengraf.

We conducted a multicenter, randomized, open labeled study to establish the equivalence between Gengraf and Neoral in stable renal transplant recipients for a treatment period of 6 months. 6 months post transplant patients with stable graft function and receiving a stable dose of neoral were recruited into the study. Eligible patients were randomly assigned to remain on Neoral or convert to an equal milligram-for-milligram dose of Gengraf. The primary end-point was serum creatinine at 26 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• Neoral
Neoral® capsule containing 25mg or 100mg cyclosporine
• Gengraf® capsule containing 25mg or 100mg cyclosporine
Transplant patients who were stable on Neoral were converted to Gengraf

Locations

Country	Name	City	State
Malaysia	Clinical Research Centre, Penang Hospital	George Town	Penang

Sponsors (1)

Lead Sponsor	Collaborator
Penang Hospital, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine level at 12 weeks	Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf	at 12 weeks	No
Secondary	CsA trough concentration and at 2 hour after CsA administration, at 2 weeks, 6 weeks 12 weeks, 6 months, 9 months and 12 months post randomization.		weeks 2, 6, 12, months 6, 9 and 12.	No