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A Phase IV, Single Center Pilot Study Using Alemtuzumab (Campath-1H) Induction Combined With Prednisone-Free, Calcineurin-Inhibitor-Free Immunosuppression in Kidney Transplantation


Phase 4
18 Years
65 Years
Open (Enrolling)
Both
Kidney Transplantation

Thank you

Trial Information

A Phase IV, Single Center Pilot Study Using Alemtuzumab (Campath-1H) Induction Combined With Prednisone-Free, Calcineurin-Inhibitor-Free Immunosuppression in Kidney Transplantation


Inclusion Criteria:



1. Patients who are male or female age 18-65 years

2. Donor age 18-65 years

3. Patients who are single-organ recipients (kidney only)

4. Women who are of childbearing potential must have a negative serum pregnancy test
before transplantation and agree to use a medically acceptable method of
contraception throughout the treatment period.

5. Subject (recipient) is able to understand the consent form and give written informed
consent

Exclusion Criteria:

1. Known sensitivity or contraindication to sirolimus, tacrolimus or MMF

2. Patient with significant or active infection

3. Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and
recipient serum

4. Patients with PRA > 20%

5. Patients who are pregnant or nursing mothers

6. Patients whose life expectancy is severely limited by diseases other than renal
disease

7. Ongoing active substance abuse, drug or alcohol

8. Major ongoing psychiatric illness or recent history of noncompliance

9. Significant cardiovascular disease (e.g.):

- Significant non-correctable coronary artery disease

- Ejection fraction below 30%

- History of recent myocardial infarction

10. Malignancy within 3 years, excluding non-melanoma skin cancers

11. Serologic evidence of infection with HIV or HBVsAg positive

12. Patients with a screening/baseline total white blood cell count < 4,000/mm3; platelet
count < 100,000/mm3; triglycerides > 400 mg/dl; total cholesterol > 300 mg/dl

13. Investigational drug within 30 days prior to transplant surgery

14. Anti-T cell therapy within 30 days prior to transplant surgery

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess the incidence of biopsy-proven acute allograft rejection during the first six months of transplant

Outcome Time Frame:

At 6 months post kidney transplant

Safety Issue:

Yes

Principal Investigator

Joseph R Leventhal, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

CEL220

NCT ID:

NCT00166712

Start Date:

April 2005

Completion Date:

October 2011

Related Keywords:

  • Kidney Transplantation
  • Kidney Transplant
  • Living Donor Kidney Transplant Recipients

Name

Location

Northwestern University/Northwestern Memorial HospitalChicago, Illinois  60611