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Study to Evaluate Safety and Immunologic Biomarker of Rapamune in Patients With Stable Renal Transplant Recipient

This study is currently recruiting participants.
Verified June 2012 by Seoul St. Mary's Hospital
Sponsor:
Information provided by (Responsible Party):
ChulWoo Yang, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01592253
First received: May 3, 2012
Last updated: June 22, 2012
Last verified: June 2012
History of Changes

May 3, 2012
June 22, 2012
May 2012
December 2013   (final data collection date for primary outcome measure)
biopsy proven acute rejection [ Time Frame: Study duration is 12 months ] [ Designated as safety issue: Yes ]
Number of episode of biopsy proven acute rejection
Same as current
Complete list of historical versions of study NCT01592253 on ClinicalTrials.gov Archive Site
Serum Creatinine, MDRD eGFR [ Time Frame: Study duration is 12 months ] [ Designated as safety issue: Yes ]
Mean diurnal Serum Creatinine, MDRD eGFR change of greater than or equal to 20% at month 12 vs baseline
Same as current
Not Provided
Not Provided
 
Study to Evaluate Safety and Immunologic Biomarker of Rapamune in Patients With Stable Renal Transplant Recipient
Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient

For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha analysis fo immune profile again. During the study period, the interval of the visit of subclinic and the kinds of laboratory test (Blood and urine test) would not change compared to before the start of this study.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Acute Rejection of Renal Transplant
Drug: Sirolimus
Beginning on day, an initial maintenance dose of 2mg/day should be given. A trough level should be obtained between days 3 and 8, and the daily dose of sirolimus should be adjusted thereafter.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Renal transplant recipient who has passed at least 10 years
  2. No acute rejection episode during the previous 6 months
  3. No change of prescription of immune suppressants
  4. Normal allograft function (MDRD eGFR > 80 mL/min/1.73 m2)
  5. Change of allograft function less than 10 % of baseline value durant the previous 1 year
  6. No proteinuria and hematuria

Exclusion Criteria:

  1. Patients who donut want to participate in this study
  2. Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)
Both
Not Provided
No
Contact: Byung Ha Chung, Assistant professor 82-2-2258-6066 chungbh@catholic.ac.kr
Korea, Republic of
 
NCT01592253
RAPA CONVERT TRIAL
No
ChulWoo Yang, Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
Not Provided
Principal Investigator: ChulWoo Yang Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP