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Completed

NCT Number: NCT00305396

Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

A prospective, single center, open-label, randomized trial of Thymoglobulin induction and sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center/Nashville VA

Nashville, Tennessee, 37232, United States

About this study

Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy and reduce long-term kidney graft survival. Complete avoidance of calcineurin inhibitors may improve graft function as measured by serum creatinine and calculated GFR and improve long-term outcomes following kidney transplantation. We conducted a prospective, randomized, single-center study comparing sirolimus versus tacrolimus in kidney transplantation. Primary cadaver of non-HLA identical living donor recipients are randomized to received either sirolimus 5 mg QD (target level 8-12 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12 ng/ml). All patients also received Thymoglobulin 1.5 mg/kg x 4 doses, mycophenolate 1 gm BID, and prednisone. Main outcome measures are patient and graft survival, biopsy-proven acute rejection, serum creatinine, hyperlipidemia, post-transplant diabetes, and surgical and wound complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primary cadaver or non-HLA identical living donor kidney transplant. -

Exclusion criteria

HIV HCV Pregnancy Age < 18 years Malignancy

-

Treatment and study plan

sirolimus

Drug

Primary outcomes

  1. Patient and graft survival

  2. Biopsy proven acute rejection

  3. Serum creatinine

Secondary outcomes

  1. Hyperlipidemia

  2. post-transplant diabetes

  3. wound infections

  4. lymphoceles

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.

Important dates

Study start
2004
Study completion
2005
First posted
Mar 21, 2006
Registry last updated
Mar 21, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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