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

Acute Rejection of Renal Transplant Clinical Trial

Official title:

Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01592253
• Other study ID #: RAPA CONVERT TRIAL
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2012
• Last updated: June 22, 2012
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: Seoul St. Mary's Hospital
• Contact: Byung Ha Chung, Assistant professor
• Phone: 82-2-2258-6066
• Email: chungbh[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Rejection of Renal Transplant

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biopsy proven acute rejection	Number of episode of biopsy proven acute rejection	Study duration is 12 months	Yes
Secondary	Serum Creatinine, MDRD eGFR	Mean diurnal Serum Creatinine, MDRD eGFR change of greater than or equal to 20% at month 12 vs baseline	Study duration is 12 months	Yes