| Trial ID: | L1508 |
| Source ID: | NCT01990118
|
| Associated Drug: |
Neoral
|
| Title: |
Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Failure
|
| Interventions: |
DRUG: Neoral|DRUG: Gengraf® capsule containing 25mg or 100mg cyclosporine
|
| Outcome Measures: |
Primary: Serum creatinine level at 12 weeks, Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf, at 12 weeks | 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.
|
| Sponsor/Collaborators: |
Sponsor: Penang Hospital, Malaysia
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
106
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-11
|
| Completion Date: |
2006-05
|
| Results First Posted: |
|
| Last Update Posted: |
2013-11-21
|
| Locations: |
Clinical Research Centre, Penang Hospital, George Town, Penang, 10990, Malaysia
|
| URL: |
https://clinicaltrials.gov/show/NCT01990118
|
