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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014