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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00177138
• Other study ID #: 0308M51264
• Secondary ID: Berlex Study No.
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 5, 2013
• Start date: July 2004
• Est. completion date: November 2006

Study information

• Verified date: February 2013
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Secondary objectives of the study are:

1. Compare the side effects of the immunosuppressive medications between both groups. This will include anaphylactic reactions, GI side-effects, bone marrow suppression, renal dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile.

2. Compare the incidence of infections between both groups.

Comparison parameters are:

1. Pancreas and kidney graft failure

2. Patient death

3. Clinical and biopsy documented rejection episodes

4. Patient dropout (non-compliance with the study protocol)

5. Kidney function as assessed by creatinine clearance or biopsy

6. Need to change immunosuppression regimen

7. Quality-adjusted Life Years

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant.

2. Recipient age 18-60 years

3. Donor age 10-59 years

4. Females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study.

5. Enteric or bladder drained pancreas transplant.

Exclusion Criteria:

1. Use of an investigational drug in the last 1-year.

2. Positive T or B cell crossmatch.

3. WBC<3000 at enrollment

4. Platelet count <50,000 at enrollment

5. History of malignancy (exclusive of minor skin cancers)

6. Inability to give informed consent

7. Systemic infections

8. Major active or chronic infections, including documented HIV infection (by any licensed ELISA and confirmation by Western Blot).

9. Serology negative for EBV pre-transplant.

10. No other previous organ transplants other than pancreas and/or kidney. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Tacrolimus
Starting POD #1 0.06 mg/kg/day in 2 divided doses;
• Alemtuzumab
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)

Locations

Country	Name	City	State
United States	University of Minnesota-Fairview	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Bayer, Gruessner, Rainer, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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