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Completed

NCT Number: NCT00777933

Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation

The use of steroids after kidney transplantation has been challenged because of variable adverse effects which may increase the patient morbidity and mortality. The aim of this study was to compare the safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients.

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Key information

Conditions

Kidney Transplantation Living Donors

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Transplantation Center, Samsung Medical Center

Seoul, 135-710, South Korea

About this study

131 patients were randomized to CsA (n = 63) or TAC (n = 68). Of 118 patients who did not have a biopsy-proven rejection episode and who had a serum creatinine level < 2.0 mg/dL 6 months after transplantation, 55 were of the CsA group and 63 were of the TAC group. We assessed patient and graft survival, acute rejection episodes, and adverse events 5 years after transplantation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • older than 15 years
  • first living donor kidney transplantation

Exclusion criteria

  • congestive heart failure (ejection fraction < 35%)
  • chronic liver disease
  • underlying diabetes mellitus
  • evidence of systemic infection at screening time
  • history of malignant disease
  • multiple organ transplantation
  • positive serologic evidence of human immunodeficiency virus

Treatment and study plan

Tacrolimus

Drug

cyclosporine

Drug

Primary outcomes

  1. Graft survival

    Time frame: 5 years

  2. Patient survival

    Time frame: 5 years

Secondary outcomes

  1. cumulative incidence of acute rejection

    Time frame: 5 years

  2. estimated glomerular filtration rate

    Time frame: 5 year

  3. new-onset diabetes mellitus

    Time frame: 5 year

  4. Hypertension

    Time frame: 5 year

  5. hyperlipidemia

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Oct 22, 2008
Registry last updated
Apr 22, 2011

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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