Simultaneous Pancreas-kidney Transplantation With Campath Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316810
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : June 19, 2012
Astellas Pharma GmbH
Information provided by (Responsible Party):
Dr. Claudia Bösmüller, Medical University Innsbruck

Brief Summary:
The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type 1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation as well as to evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of drug-related complications and immunosuppression-associated complications.

Condition or disease Intervention/treatment Phase
Pancreas-Kidney Transplantation Drug: Alemtuzumab Drug: Rabbit Anti-Human Thymocyte Globulin Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Prospective Study to Investigate the Safety and Efficacy of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy Compared to Short-course ATG-induction in Combination With Tacrolimus, Mycophenolate Mofetil and Short-term Steroids Application in de Novo SPK Transplanted Diabetic Patients
Study Start Date : April 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Arm Intervention/treatment
Experimental: Campath

Day 0: Before revascularisation patients are given 500 mg of Methylprednisolone i.v. followed by Campath 30 mg i.v. infusion over 3-6 hours.

Day 1: No treatment

Day 2: Initial dose of Tacrolimus 0.05 - 0.1 mg/kg/d orally.

till Month 6: Aim at blood level of 12-15 ng/ml (try to prevent the Tacrolimus trough level falling below 12 ng/ml in the first 6 months).

Month 7-12: Maintain the Tacrolimus blood level at 6-12 ng/ml after 6 months.

Drug: Alemtuzumab
Day 0: Campath 30 mg i.v. infusion over 3-6 hours

Active Comparator: ATG

Day 0: Prior to revascularisation patients are given 500 mg of Methylprednisolone i.v. followed by a single shot of a polyclonal antilymphocyte preparation. Tacrolimus will be given immediately after transplantation(0.05-0.1 mg/kg/d) orally. Preoperative loading dose MMF: 2 g orally.

From Day 1: Total initial daily dose of 0.05-0.1 mg/kg administered orally in 2 doses. Blood trough levels 12-15 ng/ml during the first 6 months and maintain blood levels 6-12 ng/ml after 6 months. Total daily dose of MMF is 2 g administered orally in 2 doses. Patients will receive Methylprednisolone 250 mg IV 12h post surgery and 125 mg of Methylprednisolone 24 h post transplantation.

Steroid taper (orally):

Day 2: 100 mg of Prednisolon Day 3: 80 mg of Prednisolon Day 4: 60 mg of Prednisolon Day 5: 40 mg of Prednisolon Day 6: 25 mg of Prednisolon Day 21: 20 mg of Prednisolon

Reduction by 5 mg in two week intervals/complete withdrawal by 3 months post-tx.

Drug: Rabbit Anti-Human Thymocyte Globulin
Day O: Single shot of a polyclonal antilymphocyte preparation (ATG-Fresenius - 8 mg/kg, or IMTIX-Sangstat ATG 4 mg/kg/day).

Primary Outcome Measures :
  1. Biopsy-proven (Kidney) rejection episodes [ Time Frame: Year 1 ]

Secondary Outcome Measures :
  1. Kidney/Pancreas function [ Time Frame: Month 6 and Year 1 ]
  2. Patient and graft survival [ Time Frame: Month 6 and Year 1 ]
  3. Lipid profile ( Total Cholesterol, HDL, LDL, Triglycerides, Treatment with statins) [ Time Frame: Month 6 and Year 1 ]
  4. Infections [ Time Frame: Month 6 and Year 1 ]
  5. Side effects [ Time Frame: Month 6 and Year 1 ]
  6. Blood Pressure [ Time Frame: Month 6 and Year 1 ]
  7. Treatment failure for any reason, such as permanent discontinuation of a drug, change from immunosuppressive protocol, graft loss or death [ Time Frame: Month 6 and Year 1 ]
  8. Percentage of steroid free patients [ Time Frame: Month 6 and Year 1 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients of 18 to 55 years of age with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
  • Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
  • Patient must have signed the Patient Informed Consent Form.
  • Patient must receive a primary simultaneous pancreas-kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding.
  • Patient is allergic or intolerant to Mycophenolate Mofetil, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
  • Past history of anaphylaxis following exposure to humanized monoclonal antibodies.
  • Patient has a positive T-cell crossmatch on the most recent serum specimen.
  • CMV-match: D+ / R-.
  • Patient is known for active liver disease or has significant liver disease; defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
  • Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
  • Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
  • Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
  • Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
  • Pancreatic duct occlusion technique.
  • Donor is older than 55 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316810

University Hospital Innsbruck
Innsbruck, Tyrol, Austria, 6020
Sponsors and Collaborators
Dr. Claudia Bösmüller
Astellas Pharma GmbH
Principal Investigator: Johann Pratschke, Prof. Dr. University Hospital Innsbruck, Dept. of General- and Transplant Surgery, Anichstrasse 35, A-6020 Innsbruck

Kaufman DB, Leventhal JR, Gallon G, Axelrod D, Parker MA. Experience with Campath-1H induction therapy in simultaneous pancreas-kidney transplantation. Pancreas and Islet Transplant Association 2005, Geneva, Switzerland, [060]
Thai NL, Khan A, Basu A, Tom K, Marcos A, Starzl TE, Shapiro R, Starzl TE. Pancreas transplantation under Campath-1H induction and tacrolimus monotherapy: preliminary results. The Joint Annual Meeting of the American Society of Transplant Surgeons and the American Society of Transplantation, 2005, Seattle, USA, [433]

Responsible Party: Dr. Claudia Bösmüller, Dr. med., Medical University Innsbruck Identifier: NCT00316810     History of Changes
Other Study ID Numbers: SIMPATICO
EudraCT Number: 2006-000845-21
First Posted: April 21, 2006    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Dr. Claudia Bösmüller, Medical University Innsbruck:
Campath 1H
Pancreas-kidney transplantation
prevention of acute rejection

Additional relevant MeSH terms:
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents