Comparative Pancreas Induction Study
| ISRCTN | ISRCTN44138942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44138942 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 26/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.W. Fijter, de
Scientific
Scientific
Leiden University Medical Center
Department of Nephrology
C3-P22
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262169 |
|---|---|
| jwdefijter@lumc.nl |
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Added 26/08/09: An open label, randomised, study to assess the efficacy and safety of Zenapax® (daclizumab) or a single high dose of Anti-Thymocyte Globulin (ATG-Fresenius®) for the prevention of acute rejection in patients receiving de novo simultaneous pancreas kidney transplantation treated with CellCept®, Neoral® and corticosteroids. |
| Study acronym | COMPAS |
| Study objectives | Equal in efficacy to prevent (biopsy-confirmed) early graft rejection and steroid-resistant rejection episodes in the first 6 months after a first simultaneous pancreas kidney transplantation. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Renal transplant, Pancreas transplantation |
| Intervention | Randomisation for the type of induction therapy: 1. Zenapax® (5 gifts of 1 mg/kg, with a maximum of 100 mg per dose, diluted in 50 ml of sterile 0.9% sodium chloride solution). The first dose will be administered intravenously before reperfusion of the first allograft. Subsequent doses of Zenapax® will be given 2, 4, 6, and 8 weeks after transplantation. 2. ATG-Fresenius® (single high dose of 9 mg/kg, diluted in 500 ml of sterile 0.9% sodium chloride solution). The iv infusion starts immediately after the central line is in place and the dose will be administered before reperfusion of the first allograft. All patients will be given 500 mg Solu-Medrol as an iv infusion thirty minutes before operation. All patients will receive mycophenolate mofetil (2 g/day), cyclosporin A (CsA) and prednisone. Dosing of CsA (target trough levels) and prednisone will be according to current hospital practice, aiming at cyclosporine trough levels of 200-300 ng/ml in the first three months, and 100-200 ng/ml thereafter. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Anti-Thymocyte Globulin (ATG-Fresenius®), daclizumab (Zenapax®), mycophenolate mofetil (MMF) (CellCept®), cyclosporin (Neoral®), prednisone |
| Primary outcome measure | The prevention of biopsy proven early graft rejection and steroid-resistant rejection episodes in the first 6 months after simultaneous pancreas kidney transplantation. |
| Secondary outcome measures | 1. Recurrence of autoimmune disease parameters 2. Time to first rejection, time after last prophylactic dose and number of steroid-resistant rejection episodes at 3 and 6 months after transplantation 3. Graft and patient survival 4. Immunophenotyping peripheral blood lymphocytes (CD3, CD4, CD8 and CD25 respectively) 5. Adverse events and opportunistic infections 6. After the first year, patient and graft survival and the occurrence of graft dysfunction will be monitored and documented according to local practice |
| Overall study start date | 01/10/1999 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Type 1 diabetics (C-peptide negative) with (pre)terminal or end-stage renal failure scheduled to receive a simultaneous pancreas kidney cadaveric transplantation, with either bladder or enteric drainage 2. Patients scheduled to receive mycophenolate mofetil (CellCept®), cyclosporin (Neoral®) and corticosteriods as basis immunusuppression 3. Male and female patients >18 years old 4. Patients capable of understanding the purpose and risks of the study and from whom informed consent has been obtained |
| Key exclusion criteria | 1. Pancreas after kidney transplant (PAK), pancreas transplant alone (PTA), segmental pancreatic transplant 2. Duct occlusion technique 3. Induction therapy with OKT3 planned 4. Pregnant or nursing women and women unwilling to use adequate contraception during, and three months following the conclusion of treatment with MMF 5. Patients scheduled to receive FK 506 (tacrolimus) or Azathioprine as basis immunusuppression 6. Patients with severe gastrointestinal disorders, that interfere with their ability to receive or absorb oral medication and patients with severe diarrhea 7. Patients with active peptic ulcer disease 8. Patients or their donors with serologic evidence of HIV, Hepatitis C Virus (HCV) or Hepatitis B Surface Antigen (HBsAg) in the past 9. Patients with malignancies (current or history within last 5 years) except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully 10. Patients with systemic infection requiring therapy at the time of entry to the study 11. Patients being treated with unlicenced, investigational drugs or other prohibited medication 12. Patients with any form of substance abuse or psychiatric disorder which in the opinion of the investigator might invalidate patients communication with the clinician 13. Patients with known hypersensitivity to daclizumab or to any of the components of this product |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
"ROR" |
https://ror.org/027bh9e22 |
|---|
Funders
Funder type
Industry
Roche Nederland BV (Netherlands)
No information available
Fresenius Medical Care (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2007 | Yes | No |
