Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr J.W. Fijter, de


Contact details

Leiden University Medical Center
Department of Nephrology
P.O. Box 9600
2300 RC
+31 (0)71 5262169

Additional identifiers

EudraCT number number

Protocol/serial number


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.



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Renal transplant, Pancreas transplantation


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Leiden University Medical Center
2300 RC

Sponsor information


Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
2300 RC

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Roche Nederland BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Fresenius Medical Care (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2007 results in

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