End Stage Renal FailurePhase 4NCT01990118
Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients
A Phase 4 study testing Neoral and Gengraf® capsule containing 25mg or 100mg cyclosporine in people with End Stage Renal Failure, run by Penang Hospital, Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End Stage Renal Failure
- What is being tested?
- Neoral and Gengraf® capsule containing 25mg or 100mg cyclosporine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2004to May 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Clinical Research Centre, Penang Hospital
George Town, Pulau Pinang, 10990
About this study
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]
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.
Read the 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.
- Conditions
- End Stage Renal Failure
- Being tested
- Neoral, Gengraf® capsule containing 25mg or 100mg cyclosporine
- Keywords
- Renal transplant, Renal allograft rejection, Cyclosporine, Gengraf
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoralDrug
Also called Cyclosporine
Neoral® capsule containing 25mg or 100mg cyclosporine
Gengraf® capsule containing 25mg or 100mg cyclosporineDrug
Also called Generic Cyclosporine
Transplant patients who were stable on Neoral were converted to Gengraf
| Study group | Role | What they receive |
|---|---|---|
| Neoral | Active comparator | Patients who continued to be treated with the drug Neoral. Receives: Drug: Neoral |
| Gengraf arm | Experimental | Patients were randomly selected to be converted to 'Gengraf® capsule containing 25mg or 100mg cyclosporine' Receives: Drug: Gengraf® capsule containing 25mg or 100mg cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine level at 12 weeks
Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf
Measured: at 12 weeks
Secondary outcomes (1)
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.
Measured: weeks 2, 6, 12, months 6, 9 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2004
- Primary completionDec 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr.Ong Loke Meng, Penang Hospital, Malaysia
- Investigators
- Dr.Ong L Meng, MBBS, FRCP, Principal investigator, Penang Hospital, Ministry of Health Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990118
- Sponsor's protocol ID
- 15.041
- Status last verified
- Nov 2013
- First submitted
- 4 Mar 2010
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT01990118
- Acronym / sponsor ID
- 15.041
- Conditions
- End Stage Renal Failure
- Keywords
- Renal transplant, Renal allograft rejection, Cyclosporine, Gengraf
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Study start
- Nov 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoral | Active comparator | Drug: NeoralPatients who continued to be treated with the drug Neoral. |
| Gengraf arm | Experimental | Drug: Gengraf® capsule containing 25mg or 100mg cyclosporinePatients were randomly selected to be converted to 'Gengraf® capsule containing 25mg or 100mg cyclosporine' |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoralAlso: CyclosporineNeoral® capsule containing 25mg or 100mg cyclosporine | Drug | Neoral |
| Gengraf® capsule containing 25mg or 100mg cyclosporineAlso: Generic CyclosporineTransplant patients who were stable on Neoral were converted to Gengraf | Drug | Gengraf arm |
Primary outcome
Serum creatinine level at 12 weeks
Time frame: at 12 weeks
Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
Related trials for End Stage Renal Failure
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Not yet recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 1
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
End Stage Renal Disease
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Ong L Meng, MBBS, FRCP principal investigator
Penang Hospital, Ministry of Health Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neoral and Gengraf® capsule containing 25mg or 100mg cyclosporine in people with End Stage Renal Failure, run by Penang Hospital, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine level at 12 weeks (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.