Back to resultsGengraf Conversion Study in Stable Renal Allograft Transplant Recipients
Primary Purpose
End Stage Renal Failure
Status
Completed
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Neoral
Gengraf® capsule containing 25mg or 100mg cyclosporine
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Failure focused on measuring Renal transplant, Renal allograft rejection, Cyclosporine, Gengraf
Eligibility Criteria
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
Sites / Locations
- Clinical Research Centre, Penang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Neoral
Gengraf arm
Arm Description
Patients who continued to be treated with the drug Neoral.
Patients were randomly selected to be converted to 'Gengraf® capsule containing 25mg or 100mg cyclosporine'
Outcomes
Primary Outcome Measures
Serum creatinine level at 12 weeks
Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01990118
First Posted
March 4, 2010
Last Updated
November 15, 2013
Sponsor
Penang Hospital, Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT01990118
Brief Title
Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients
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]
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penang Hospital, Malaysia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure
Keywords
Renal transplant, Renal allograft rejection, Cyclosporine, Gengraf
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neoral
Arm Type
Active Comparator
Arm Description
Patients who continued to be treated with the drug Neoral.
Arm Title
Gengraf arm
Arm Type
Experimental
Arm Description
Patients were randomly selected to be converted to 'Gengraf® capsule containing 25mg or 100mg cyclosporine'
Intervention Type
Drug
Intervention Name(s)
Neoral
Other Intervention Name(s)
Cyclosporine
Intervention Description
Neoral® capsule containing 25mg or 100mg cyclosporine
Intervention Type
Drug
Intervention Name(s)
Gengraf® capsule containing 25mg or 100mg cyclosporine
Other Intervention Name(s)
Generic Cyclosporine
Intervention Description
Transplant patients who were stable on Neoral were converted to Gengraf
Primary Outcome Measure Information:
Title
Serum creatinine level at 12 weeks
Description
Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Ong L Meng, MBBS, FRCP
Organizational Affiliation
Penang Hospital, Ministry of Health Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Centre, Penang Hospital
City
George Town
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
12. IPD Sharing Statement
Learn more about this trial
Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients
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