Calcineurin Inhibitor Based Immunosuppression Withdrawal

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Damage and scarring of a transplanted kidney has become the most common cause of loss of the transplanted kidney. This kidney damage is a complex process caused by many factors including injury during obtaining and transplanting the kidney, injury from the immune system, injury from infections, and injury from drugs used to stop rejection. This injury leads to scars that decrease the kidney's ability to function properly, and over time the kidney is lost. Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when used over time it has been shown to cause chronic damage and scarring in the transplanted kidney.

The purpose of this experimental study is to determine whether children can safely be withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent research studies in adult transplantation have demonstrated that with the use of Rapamycin® (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase in rejection, with decreased scarring in the kidney, and with improvements in kidney function and survival of the kidney. A total of 50 children will enroll in this study at university centers around the country. This study will last about 3 years.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pediatric Nephrology of Alabama
• Collaborators: Pfizer; The Emmes Company, LLC; The EMMES Corporation
• Treatments: Calcineurin Inhibitors; Everolimus; Sirolimus

Criteria

Inclusion Criteria at Transplant:

• Age < 19 years (up to the day of the 19th birthday)

• Panel Reactive Antibody Level (PRA) <20% (Flow cytometry method)

• Recipient of first living donor or deceased donor renal transplantation

• Signed and dated informed consent (per local IRB standards)

Exclusion Criteria at Transplant:

• Recipients of multi-organ transplants (e.g. kidney/pancreas transplant, etc.)

• Peak PRA > 20% at any time

• Recipient of en-bloc kidneys

• Recipient of an organ from an HLA identical donor or a non-heart beating donor

• Pregnant or lactating

• Positive for HIV or an immunodeficiency virus

• History of malignancy

• Use of investigational agents within 4 weeks prior to transplantation

• Current use of terfenadine, cisapride, astemizole, or pimozide (unless discontinued before administration of SRL)

• Known hypersensitivity to sirolimus

• Known hypersensitivity to Prograf, Cellcept, prednisone, Cremophor, HCO-60, or murine products