Randomized Trial of Cyclosporine and Tacrolimus Therapy W... | NCT00777933

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

NCT00777933

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Apr 22, 2011Estimated

Enrollment

131Actual

Phase

Not Applicable

Conditions

Kidney Transplantation
Living Donors

Interventions

tacrolimus
cyclosporine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2000

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Oct 21, 2008

First Submission Date that Met QC Criteria

Oct 21, 2008

First Posted Date

Oct 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2011

Last Update Posted Date

Apr 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

131Actual

Label	Type	Description	Intervention Names
cyclosporine	Active Comparator		Drug: cyclosporine
Tacrolimus	Experimental		Drug: tacrolimus

Name	Type	Description	Arm Group Labels	Other Names
tacrolimus	Drug		Tacrolimus
cyclosporine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Graft survival		5 years
Patient survival		5 years

Secondary Outcomes

Measure	Description	Time Frame
cumulative incidence of acute rejection		5 years
estimated glomerular filtration rate		5 year
new-onset diabetes mellitus

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jae-Won Joh, MD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Transplantation Center, Samsung Medical Center		Seoul		135-710	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19744223	Derived	Lee YJ, Kim B, Lee JE, Kim YG, Kim DJ, Kim SJ, Joh JW, Oh HY, Huh W. Randomized trial of cyclosporine and tacrolimus therapy with steroid withdrawal in living-donor renal transplantation: 5-year follow-up. Transpl Int. 2010 Feb;23(2):147-54. doi: 10.1111/j.1432-2277.2009.00955.x. Epub 2009 Sep 9.

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D003524	Cyclosporins