Condition category
Surgery
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes