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Simultaneous Pancreas-Kidney Transplantation With Campath Protocol
This study is not yet open for participant recruitment.
Verified by Medical University Innsbruck, April 2006
First Received: April 19, 2006   No Changes Posted
Sponsor: Medical University Innsbruck
Collaborator: Astellas Pharma GmbH
Information provided by: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT00316810
  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)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 (Banff Classification)

Secondary Outcome Measures:
  • Kidney/Pancreas function
  • Kidney function will be measured by:
  • S- creatinine,
  • Creatinine clearance (Cockroft measurement)
  • Pancreas function will be measured by:
  • Fasting Glucose level (< 123 mg/dl)
  • HbA1C
  • C-peptide
  • Need for insulin therapy
  • Need for oral antidiabetic medication
  • Patient and graft survival
  • Lipid profile ( total cholesterol, HDL, LDL, triglycerides, treatment with statins)
  • Infections
  • Side effects
  • Blood Pressure
  • Treatment failure for any reason, such as permanent discontinuation of a drug, change from immunosuppressive protocol, graft loss or death
  • Percentage of steroid free patients

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: April 2009
  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

Contacts
Contact: Raimund Margreiter, Prof. Dr. +43 512 504 ext 22600 raimund.margreiter@uibk.ac.at
Contact: Claudia Boesmueller, Dr. +43 512 504 ext 81009 claudia.boesmueller@uibk.ac.at

Locations
Austria
University Hospital Innsbruck
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Astellas Pharma GmbH
Investigators
Principal Investigator: Raimund Margreiter, Prof. Dr. University Hospital Innsbruck, Dept. of General- and Transplant Surgery, Anichstrasse 35, A-6020 Innsbruck
  More Information

Publications:
Robertson P, Davis C, Larsen J, Stratta R, Sutherland DE; American Diabetes Association. Pancreas transplantation in type 1 diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S105. No abstract available.
Sutherland DE, Gruessner RW, Dunn DL, Matas AJ, Humar A, Kandaswamy R, Mauer SM, Kennedy WR, Goetz FC, Robertson RP, Gruessner AC, Najarian JS. Lessons learned from more than 1,000 pancreas transplants at a single institution. Ann Surg. 2001 Apr;233(4):463-501. Review.
Bechstein WO, Malaise J, Saudek F, Land W, Fernandez-Cruz L, Margreiter R, Nakache R, Secchi A, Vanrenterghem Y, Tyden G, Van Ophem D, Berney T, Boucek P, Landgraf R, Kahl A, Squifflet JP; EuroSPK Study Group. Efficacy and safety of tacrolimus compared with cyclosporine microemulsion in primary simultaneous pancreas-kidney transplantation: 1-year results of a large multicenter trial. Transplantation. 2004 Apr 27;77(8):1221-8.
Burke GW 3rd, Kaufman DB, Millis JM, Gaber AO, Johnson CP, Sutherland DE, Punch JD, Kahan BD, Schweitzer E, Langnas A, Perkins J, Scandling J, Concepcion W, Stegall MD, Schulak JA, Gores PF, Benedetti E, Danovitch G, Henning AK, Bartucci MR, Smith S, Fitzsimmons WE. Prospective, randomized trial of the effect of antibody induction in simultaneous pancreas and kidney transplantation: three-year results. Transplantation. 2004 Apr 27;77(8):1269-75.
Stratta RJ, Alloway RR, Lo A, Hodge E. Two-dose daclizumab regimen in simultaneous kidney-pancreas transplant recipients: primary endpoint analysis of a multicenter, randomized study. Transplantation. 2003 Apr 27;75(8):1260-6.
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]
Gruessner RW, Kandaswamy R, Humar A, Gruessner AC, Sutherland DE. Calcineurin inhibitor- and steroid-free immunosuppression in pancreas-kidney and solitary pancreas transplantation. Transplantation. 2005 May 15;79(9):1184-9.

Study ID Numbers: SIMPATICO, EudraCT number: 2006-000845-21
Study First Received: April 19, 2006
Last Updated: April 19, 2006
ClinicalTrials.gov Identifier: NCT00316810     History of Changes
Health Authority: Austria: Federal Ministry for Health and Women

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

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

ClinicalTrials.gov processed this record on February 08, 2010