Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

Kidney Transplant Patients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680952
• Other study ID #: 4-2011-0920
• Status: Completed
• Phase: Phase 4
• First received: September 4, 2012
• Last updated: March 7, 2016
• Start date: September 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged over 20 years

• Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator

• Patients has given written informed consent

• Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.)

• Patients has received an ABO compatible donor kidney.

• Complement-dependent Cytotoxic Crossmatch: CDC) result: negative

• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion Criteria:

• Patient has previously received an organ transplant other than a kidney.

• Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil.

• Desensitization

• HLA-identical

• Heart Disease; Heart failure (symptom, EF <45%)

• Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease

• Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable

• malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma)

• Patient has received a kidney transplant from non-heart beating donor

• Cold ischemic time > 30hrs

• Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site

• (ANC)<1,500/mm3, (WBC)<2,500/ mm3, (PLT)<100,000/ mm3

• ATG: Anti-thymocyte globulin induction

• Medical condition that could interfere with the study objectives.

• Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment.

• Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment.

• Patient who is judged not to be adequate by the investigator owing to other reasons

• Patient is pregnant or lactating.

• Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplant Patients

Intervention

Drug:
• A) TEST
Extended Release Tacrolimus (Advagraf®) ? Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. ? Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. Sirolimus (Rapamune®): After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.
• B) CONTROL
Extended Release Tacrolimus (Advagraf®) : Same as above. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national hospital	Daegu
Korea, Republic of	Gangnam Severance hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University hospital	Seoul
Korea, Republic of	Severance hospital	Seoul
Korea, Republic of	Ajou Univeristy Medical Center	Suwon	KyungKi Province
Korea, Republic of	Ulsan Univ Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure rate in effectiveness of up to 12 months after kidney transplant	Biopsy confirmed acute rejection; Subjects and graft survival; Glomerular filtration rate (GFR); 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.	12 months after kidney transplant	No