Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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End Stage Renal Failure

Intervention / Treatment
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* Drug: Neoral
* Drug: Gengraf® capsule containing 25mg or 100mg cyclosporine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neoral<br>Patients who continued to be treated with the drug Neoral. | Drug: Neoral<br>* Neoral® capsule containing 25mg or 100mg cyclosporine<br>* Other names: Cyclosporine;|
| Experimental: Gengraf arm<br>Patients were randomly selected to be converted to 'Gengraf® capsule containing 25mg or 100mg cyclosporine' | Drug: Gengraf® capsule containing 25mg or 100mg cyclosporine<br>* Transplant patients who were stable on Neoral were converted to Gengraf<br>* Other names: Generic Cyclosporine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine level at 12 weeks | Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | weeks 2, 6, 12, months 6, 9 and 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplant, Renal allograft rejection, Cyclosporine, Gengraf