- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01990118
Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients
A Randomized, Multi-center, Open Label Trial to Establish the Therapeutic Equivalence Between Neoral® and Gengraf® in Stable Renal Allograft Recipients [Gengraf Conversion Study]
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Penang
-
George Town, Penang, Malaysia, 10990
- Clinical Research Centre, Penang Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent obtained from patient or parents/guardian.
- Patients who are more than 6 months post transplant
- Stable graft function i.e. serum creatinine less than 300 umol/l
- Patients currently on a stable dose of capsule Neoral within last one month
Exclusion Criteria:
- Multiple organ transplantation
- 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.
- Participation in any drug trial in which the patient received an investigational drug within 30 days preceding the screening phase of this study.
- Those persons directly involved in the conduct of the study.
- Active infection at the time of screening for enrollment into trial.
- Acute graft rejection within the past 3 months
- Mentally unstable or history of mental diseases
- History of drug or alcohol abuse within the past 2 years.
- History of non-compliance to medical regimen and patients who are unwilling or unable to comply with the protocol.
- Decompensated liver disease
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Neoral
Patients who continued to be treated with the drug Neoral.
|
Neoral® capsule containing 25mg or 100mg cyclosporine
Other Names:
|
EXPERIMENTAL: Gengraf arm
Patients were randomly selected to be converted to 'Gengraf® capsule containing 25mg or 100mg cyclosporine'
|
Transplant patients who were stable on Neoral were converted to Gengraf
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum creatinine level at 12 weeks
Time Frame: at 12 weeks
|
Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf
|
at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: weeks 2, 6, 12, months 6, 9 and 12.
|
weeks 2, 6, 12, months 6, 9 and 12.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr.Ong L Meng, MBBS, FRCP, Penang Hospital, Ministry of Health Malaysia
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- 15.041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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