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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777933
• Other study ID #: 2000-07-02
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: April 21, 2011
• Start date: July 2000
• Est. completion date: May 2008

Study information

• Verified date: April 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation
• Living Donors

Intervention

Drug:
• tacrolimus

• cyclosporine

Locations

Country	Name	City	State
Korea, Republic of	Transplantation Center, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft survival		5 years	No
Primary	Patient survival		5 years	No
Secondary	cumulative incidence of acute rejection		5 years	No
Secondary	estimated glomerular filtration rate		5 year	No
Secondary	new-onset diabetes mellitus		5 year	Yes
Secondary	Hypertension		5 year	Yes
Secondary	hyperlipidemia		5 year	Yes