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

NCT01680952 | Completed Phase 4

• 1 other identifier: 4-2011-0920
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 7

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

Keywords

RECORD study

Outcome Measures

Primary Outcomes (1)

• Failure rate in effectiveness of up to 12 months after kidney transplant

  1. Biopsy confirmed acute rejection 2. Subjects and graft survival 3. Glomerular filtration rate (GFR) 4. 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.

  12 months after kidney transplant

Study Arms (2)

A) TEST

ACTIVE COMPARATOR

Drug: A) TEST; Drug: B) CONTROL

B) CONTROL

EXPERIMENTAL

Drug: A) TEST; Drug: B) CONTROL

Interventions

A) TEST 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.

Also known as: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)

A) TEST; B) CONTROL

B) CONTROL 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

Also known as: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil

A) TEST; B) CONTROL

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (7)

Kyungpook national hospital

Daegu, Daegu, South Korea

Location

Ajou Univeristy Medical Center

Suwon, KyungKi Province, South Korea

Location

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

Gangnam Severance hospital

Seoul, Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, Seoul, South Korea

Location

Seoul National University hospital

Seoul, Seoul, South Korea

Location

Ulsan Univ Hospital

Ulsan, Ulsan, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28810721 DERIVED

MeSH Terms

Interventions

Sirolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

KR (7)