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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 2

Tacrolimus/MMF/TMG

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

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

Group 1

Campath/MMF/TMG

Group Type EXPERIMENTAL

Alemtuzumab

Intervention Type 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)

Interventions

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Tacrolimus

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

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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.

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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. -

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No