Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

NCT00177138 | Terminated Phase 4

• 2 other identifiers: 0308M51264Berlex Study No. 107.G0001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview. Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2). This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.

Conditions

Diabetes Mellitus

Keywords

Campath Study; Pancreas After Kidney Transplantation; Alemtuzumab

Outcome Measures

Primary Outcomes (1)

• Time-to-event analysis will be used to analyze categorical end points that include graft failure, patient survival, biopsy documented rejection episode and non-compliance.

  2 years

Secondary Outcomes (1)

• The continuous outcome variable, weekly or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance.

  2 years

Study Arms (2)

Group 2

ACTIVE COMPARATOR

Tacrolimus/MMF/TMG

Drug: Tacrolimus

Group 1

EXPERIMENTAL

Campath/MMF/TMG

Drug: Alemtuzumab

Interventions

Tacrolimus DRUG

Starting POD #1 0.06 mg/kg/day in 2 divided doses;

Group 2

Alemtuzumab DRUG

30 mg IV intra-op and POD #12; then 30 mg IV \>monthly for 1 year (only if ALC\>200 mm, up to a total of 10 doses in year)

Group 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant.
• Recipient age 18-60 years
• Donor age 10-59 years
• Females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study.
• Enteric or bladder drained pancreas transplant.

You may not qualify if:

• Use of an investigational drug in the last 1-year.
• Positive T or B cell crossmatch.
• WBC\<3000 at enrollment
• Platelet count \<50,000 at enrollment
• History of malignancy (exclusive of minor skin cancers)
• Inability to give informed consent
• Systemic infections
• Major active or chronic infections, including documented HIV infection (by any licensed ELISA and confirmation by Western Blot).
• Serology negative for EBV pre-transplant.
• No other previous organ transplants other than pancreas and/or kidney. -

Sponsors & Collaborators

• University of Minnesota: lead
• Bayer: collaborator
• Gruessner, Rainer, MD: collaborator

Study Sites (1)

University of Minnesota-Fairview

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Tacrolimus; Alemtuzumab

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rainer W Gruessner, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2004
• Study Completion: November 1, 2006
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (1)