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CompletedNCT00777933Updated Apr 22, 2011

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

An interventional study of tacrolimus and cyclosporine in Kidney Transplantation and Living Donors, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2011-04-22.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Kidney Transplantation
  • Living Donors
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Browse Samsung Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • older than 15 years
  • first living donor kidney transplantation

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
131 participants (actual)

Study arms

  • Active comparator
    cyclosporine

    Drug: cyclosporine

  • Experimental
    Tacrolimus

    Drug: tacrolimus

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Transplantation Center, Samsung Medical Center
    Seoul, 135-710, South Korea
08

References and documents

Publications

  • 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. PubMed 19744223 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2000, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2008
First posted
Oct 22, 2008
Start
Jul 2000
Primary completionActual
May 2008
CompletionActual
May 2008
Last update
Apr 22, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00777933
Lead sponsor
Samsung Medical Center
First posted
Oct 22, 2008
Start date
Jul 2000
Primary completion
May 2008
Completion
May 2008
Last update
Apr 22, 2011

Study contacts

Jae-Won Joh, MD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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