Simultaneous Pancreas-kidney Transplantation With Campath Protocol

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma GmbH
Information provided by (Responsible Party):
Dr. Claudia Bösmüller, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00316810
First received: April 19, 2006
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Pancreas-Kidney Transplantation
Drug: Alemtuzumab
Drug: Rabbit Anti-Human Thymocyte Globulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Biopsy-proven (Kidney) rejection episodes [ Time Frame: Year 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Kidney/Pancreas function [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
  • Patient and graft survival [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
  • Lipid profile ( Total Cholesterol, HDL, LDL, Triglycerides, Treatment with statins) [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
  • Infections [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of steroid free patients [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2006
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: MABCAMPATH
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).
Other Name: ATG-S FRESENIUS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316810

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

Publications:
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
ClinicalTrials.gov Identifier: NCT00316810     History of Changes
Other Study ID Numbers: SIMPATICO, EudraCT Number: 2006-000845-21
Study First Received: April 19, 2006
Last Updated: June 18, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University Innsbruck:
Campath 1H
Alemtuzumab
Tacrolimus
Pancreas-kidney transplantation
immunosuppression
prevention of acute rejection

Additional relevant MeSH terms:
Tacrolimus
Campath 1G
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014