search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Comparative Pancreas Induction Study.


- candidate number1671
- NTR NumberNTR479
- ISRCTNISRCTN44138942
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDsN/A 
- Public TitleComparative Pancreas Induction Study.
- Scientific TitleAn open label, randomized, study to assess the efficacy and safety of Zenapax® (daclizumab) or a single high dose of Anti Thymocyte Globulin (Fresenius) for the prevention of acute rejection in patients receiving de novo simultaneous pancreas kidney transplantation treated with CellCept®, Neoral® and corticosteroids.
- ACRONYMCOMPAS
- hypothesisEqually 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.
- Healt Condition(s) or Problem(s) studiedRenal transplant , Pancreas transplantation
- Inclusion criteria1. 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.
- Exclusion criteria1. 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, HCV or 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-1999
- planned closingdate1-jun-2005
- Target number of participants40
- InterventionsRandomization for the type of induction therapy:
A) 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.
B) ATG-Fresenius® (single high dose of 9 mg/kg, diluted in 500 mL of sterile 0.9% sodium chloride solution) The i.v. 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 i.v. infusion thirty minutes before operation. All patients will receive mycophenolate mofetil (2 g/day), CsA and prednisone. Dosing of CsA (target trough levels) and prednisone will be according to current hospital practice, aiming at cyclosporin trough levels of 200-300 ng/ml in the first three months, and 100-200 ng/ml thereafter.
- Primary outcomeThe prevention of biopsy proven early graft rejection and steroid-resistant rejection episodes in the first 6 months after simultaneous pancreas kidney transplantation.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. J.W. Fijter, de
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.W. Fijter, de
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV, Fresenius Medical Care
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD15-sep-2005 - 9-jul-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl