Contact information
Type
Scientific
Primary contact
Dr J.W. Fijter, de
ORCID ID
Contact details
Leiden University Medical Center
Department of Nephrology
C3-P22
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262169
jwdefijter@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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.
Acronym
COMPAS
Study hypothesis
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
Received from local medical ethics committee
Study design
Multicentre randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Anti-Thymocyte Globulin (ATG-Fresenius®), daclizumab (Zenapax®), mycophenolate mofetil (MMF) (CellCept®), cyclosporin (Neoral®), prednisone
Primary outcome measures
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 trial start date
01/10/1999
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/10/1999
Recruitment end date
01/06/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Funders
Funder type
Industry
Funder name
Roche Nederland BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Fresenius Medical Care (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17459076
Publication citations
-
Results
van de Linde P, Vd Boog PJ, Tysma OM, Elliott JF, Roelen DL, Claas FH, de Fijter JW, Roep BO, Selective unresponsiveness to beta cell autoantigens after induction immunosuppression in pancreas transplantation with anti-interleukin-2 receptor antibody versus anti-thymocyte globulin., Clin. Exp. Immunol., 2007, 149, 1, 56-62, doi: 10.1111/j.1365-2249.2007.03400.x.