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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01592253
Recruitment Status : Unknown
Verified June 2012 by ChulWoo Yang, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : May 7, 2012
Last Update Posted : June 25, 2012
Information provided by (Responsible Party):
ChulWoo Yang, Seoul St. Mary's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Rejection of Renal Transplant Drug: Sirolimus Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient
Study Start Date : May 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

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.

Primary Outcome Measures :
  1. biopsy proven acute rejection [ Time Frame: Study duration is 12 months ]
    Number of episode of biopsy proven acute rejection

Secondary Outcome Measures :
  1. Serum Creatinine, MDRD eGFR [ Time Frame: Study duration is 12 months ]
    Mean diurnal Serum Creatinine, MDRD eGFR change of greater than or equal to 20% at month 12 vs baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01592253

Contact: Byung Ha Chung, Assistant professor 82-2-2258-6066

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul St. Mary's Hospital
Principal Investigator: ChulWoo Yang Seoul St. Mary's Hospital

Responsible Party: ChulWoo Yang, professor, Seoul St. Mary's Hospital Identifier: NCT01592253     History of Changes
Other Study ID Numbers: RAPA CONVERT TRIAL
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Calcineurin Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action