Evaluating the Use of Thymoglobulin, Sirolimus, and Donor Bone Marrow With Kidney Transplantation Patients

Completed · Phase 2

Conditions studied: Kidney Transplantation

In brief

Patients with renal failure need chronic dialysis or a kidney transplant to survive. Most kidney transplant patients must take medicines indefinitely to prevent their immune systems from rejecting the kidney. Long-term exposure to these anti-rejection medicines can damage the transplanted kidney. The purpose of this study is to determine whether giving patients cells from the donor's bone marrow will reduce or eliminate the need for long-term use of these anti-rejection drugs. In addition to the donor's bone marrow cells, patients will receive the drugs thymoglobulin and sirolimus. A total of 20 patients will participate in this five-year study.

Key facts

Study ID

NCT00062712

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

20

Starts

2003-06-09

Expected to finish

2007-03-22

Last updated by the study team

2017-07-02

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Immunosuppressive drug therapy at the time of or 2 months prior to enrollment. Specifically, candidates may not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, antilymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive.
• Treatment with a nucleoside analogue chemotherapeutic agent (i.e. fludarabine phosphate, cladribine, or pentostatin) within 12 months of kidney transplant.
• Absolute lymphocyte count less than 1000/mm(3) prior to first dose of Thymogobulin.
• Any active malignancy or any history of a hematologic malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing the lesions are appropriately treated prior to transplant.
• Donor/recipient combinations in which there are 0 HLA mismatches or in which the donor is homozygous for a shared HLA haplotype. Serologic HLA typing to be conducted at the Walter Reed Army Medical Center Tissue Typing Laboratory.
• Sensitization as defined by historical or current PRA less than 20 percent in patients receiving their first kidney allograft.
• First kidney graft survival less than 3 years as a consequence of acute/chronic rejection or positive T or B cell crossmatch in patients receiving second kidney allograft.
• Historical or current positive T cell cross match between donor and recipient.
• Significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol allograft biopsies.
• Platelet count less than 75,000/mm(3) at the time of transplant.
• Any known immunodeficiency syndrome such as HIV, Chronic Granulomatous Disease, Severe Combined Immunodeficiency, DiGeorge Syndrome, etc.
• Presence of uncorrected cardiac insufficiency (either valvular or vascular) or major vascular disease.
• Subjects unwilling/unable to practice birth control if potentially fertile.
• Presence of active or chronic infection.
• Any condition that would likely increase the risk of protocol participation or confound data interpretation such as inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services, or access to anti-rejection drugs after the research protocol is completed.
• Any history of allergy or anaphalaxis to rabbit proteins.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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