Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

Summary

Transplant rejection occurs when a patient's body does not recognize the new organ and attacks it. Patients who have kidney transplants must take drugs to prevent transplant rejection. Alemtuzumab is a man-made antibody used to treat certain blood disorders. The purpose of this study is to test the safety and effectiveness of using alemtuzumab in combination with two other drugs, sirolimus and tacrolimus, to prevent organ rejection after kidney transplantation. This study will also test whether this combination of medications will allow patients to eventually stop taking antirejection medications entirely.

Study hypothesis: A new strategy of immunosuppression using alemtuzumab, tacrolimus, and sirolimus for human renal transplantation will permit a step-wise withdrawal from immunosuppressive drugs.

Conditions

• Kidney Transplantation
• Kidney Disease

Interventions

DRUG

Alemtuzumab

30mg intravenous infusion on days 0 (transplant), 1, and 2

DRUG

Sirolimus

2mg/day orally within 24-48 hrs post-transplant, and adjusted to achieve blood levels of 8-12 ng/mL for 1 year

DRUG

Tacrolimus

2mg orally twice daily, on days 1-60

PROCEDURE

Kidney transplant

Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)

DRUG

Methylprednisolone (or equivalent)

250 mg intravenous infusion 60 minutes prior to first dose of alemtuzumab

DRUG

Acetaminophen

650 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis

DRUG

Diphenhydramine

25 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis

DRUG

Trimethoprim (TMP)/Sulfa (Bactrim, Septra)

1 double strength tablet 3 times a week from day 1 through 1 year post-transplant.

DRUG

Valgancyclovir

Given orally beginning on day 1 for up to 10 days post-transplant (until participant discharged from hospital if prior to 10 days). Dose adjusted based on participants calculated creatinine clearance

DRUG

Acyclovir

400 mg orally twice daily or 800 mg orally four times daily (dose adjusted based on calculated creatinine clearance and cytomegalovirus antibody serologic status of donor and recipient) for a minimum of 3 months starting when valganciclovir discontinued.

DRUG

Pentamidine

300 mg/6 mL inhalation therapy once monthly for a total of 6 treatments. First treatment given within one week post-transplant for participants with a known allergy or intolerance to sulfa

DRUG

Clotrimazole

10 mg orally four times daily for a minimum of 3 months post-transplant (subjects take either clotrimazole or nystatin, not both)

DRUG

Nystatin

500,000 units/5 mL orally four times daily for a minimum of 3 months post-transplant (subjects take either nystatin or clotrimazole, not both)

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• A. D'jamali, MD, MS · Immune Tolerance Network (ITN)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-11-30

Primary Completion

2010-02-28

Completion

2010-02-28

Countries

• United States

Study Locations