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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
  Purpose

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.


Condition Intervention
Acute Rejection of Renal Transplant
 Drug: Sirolimus

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • biopsy proven acute rejection [ Time Frame: Study duration is 12 months ] [ Designated as safety issue: Yes ]
    Number of episode of biopsy proven acute rejection


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592253

Contacts
Contact: Byung Ha Chung, Assistant professor 82-2-2258-6066 chungbh@catholic.ac.kr

Locations
Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
Principal Investigator: ChulWoo Yang Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: ChulWoo Yang, professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01592253     History of Changes
Other Study ID Numbers: RAPA CONVERT TRIAL
Study First Received: May 3, 2012
Last Updated: June 22, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 21, 2013