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

NCT ID: NCT01680952

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-01-31

Brief 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.

Conditions

Kidney Transplant Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A) TEST

Group Type: ACTIVE_COMPARATOR

A) TEST

Intervention Type: DRUG

1. Extended Release Tacrolimus (Advagraf®)

① 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.

② 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.

2. Sirolimus (Rapamune®):

After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.

B) CONTROL

Intervention Type: DRUG

1. Extended Release Tacrolimus (Advagraf®)

: Same as above.

2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid

B) CONTROL

Group Type: EXPERIMENTAL

A) TEST

Intervention Type: DRUG

1. Extended Release Tacrolimus (Advagraf®)

① 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.

② 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.

2. Sirolimus (Rapamune®):

After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.

B) CONTROL

Intervention Type: DRUG

1. Extended Release Tacrolimus (Advagraf®)

: Same as above.

2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid

Interventions

A) TEST

1. Extended Release Tacrolimus (Advagraf®)

① 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.

② 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.

2. Sirolimus (Rapamune®):

After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.

Intervention Type: DRUG

B) CONTROL

1. Extended Release Tacrolimus (Advagraf®)

: Same as above.

2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid

Intervention Type: DRUG

Other Intervention Names

1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®); 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kyungpook national hospital

Daegu, Daegu, South Korea

Ajou Univeristy Medical Center

Suwon, KyungKi Province, South Korea

Severance hospital

Seoul, Seoul, South Korea

Gangnam Severance hospital

Seoul, Seoul, South Korea

Korea University Anam Hospital

Seoul, Seoul, South Korea

Seoul National University hospital

Seoul, Seoul, South Korea

Ulsan Univ Hospital

Ulsan, Ulsan, South Korea

Countries

South Korea

References

Huh KH, Lee JG, Ha J, Oh CK, Ju MK, Kim CD, Cho HR, Jung CW, Lim BJ, Kim YS; RECORD Study. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial. Nephrol Dial Transplant. 2017 Aug 1;32(8):1415-1424. doi: 10.1093/ndt/gfx093.

Reference Type: DERIVED

PMID: 28810721 (View on PubMed)

Other Identifiers

4-2011-0920

Identifier Type: -

Identifier Source: org_study_id