Evaluate Efficacy Study of Combination Therapy of Everolimus and Low Dose Tacrolimus in Renal Allograft Recipients

NCT ID: NCT02036554

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-12-31

Brief Summary

To evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset Diabetes Mellitus after transplantation in the renal allograft recipients

Detailed Description

An open-label, randomized, multi-center, comparative parallel study to evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset Diabetes Mellitus after transplantation in the renal allograft recipients: PROTECT study

Conditions

Kidney; Complications, Allograft

Study Design

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

Study Groups

Tacrolimus plus Everolimus

Low dose Tacrolimus + Everolimus

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: DRUG

Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.

Tacrolimus

Intervention Type: DRUG

Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.

Tacrolimus plus Mycophenolic acid

standard dose Tacrolimus + Mycophenolic acid

Group Type: ACTIVE_COMPARATOR

Tacrolimus

Intervention Type: DRUG

Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.

Mycophenolic acid

Intervention Type: DRUG

Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.

Interventions

Everolimus

Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.

Intervention Type: DRUG

Tacrolimus

Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.

Intervention Type: DRUG

Mycophenolic acid

Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.

Intervention Type: DRUG

Other Intervention Names

Certican; Tacroli; Cellcept

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 20 year old

2. At least 3 months after kidney transplantation

3. Subject who is using Tacrolimus ± purine synthesis inhibitor + steroid without change within the past 3 months (except the dosage)

4. MDRD eGFR ≥ 50 mL/min or serum creatinine < 2.0mg/dL within the past 3 months in the 6months after kidney transplantation

5. Rate of change of serum creatinine < +30% within the past 3 months in the 6months after kidney transplantation (if serum creatinine decreased, without rate of change is inclusion possible. if serum creatinine result was normal,regardless of the rate of change is able to register.)

6. Urine protein/creatinine ratio < 1g/g Cr (spot urine) Subject who is not applicable to the diagnostic criteria NODAT on

7. the baseline in the 6months after kidney transplantation

8. Subjects who agree with written informed consent

Exclusion Criteria

1. Subjects who received combined non-renal transplantation

2. Subject who received re-transplantation

3. ABO blood group incompatible(when anti-ABO Antibody titer <1:128 is inclusion possible.)

4. Sensitized patients before transplantation

• Pretransplant or peak PRA titer > 50%
• Pretransplant T cell cytotoxicity crossmatch (+)

5. HLA-identical living related donor

6. Subject who has diabetes mellitus / NODAT before transplantation

7. Subject who has suffered acute rejection episode within the past 3 months in the 6months after kidney transplantation

8. Subject with hypersensitivity to everolimus

9. Subject who should continue nephrotoxic drug until enrollment (Aminoglycoside, amphotericin B, cisplatin)

10. Subject with GI disorder that might interfere with the ability to absorb oral medication. (eg, gastrectomy or insufficiently treated diabetic gastroenteropathy)

11. Subjects with active peptic ulcer

12. HIV, HBsAg, or HCV Ab tests (+)

13. Abnormal liver function test (AST or ALT or total bilirubin> upper normal limit x3)

14. ANC <1.5*109/L or WBC <2.5*109/L or platelet <75*109/L

15. Treatment with an investigational drug within 30 days preceding the first dose of trial medication

16. Women who are either pregnant, lactating, planning to become pregnant in the next 12 months.

17. Subjects with history of cancer(except successfully treated), localized nonmelanocytic skin cancer, PTLD(Post-transplant lymphoproliferative disorder)

18. Subjects with clinically significant infections within the past 4 weeks in the 6months after kidney transplantation

19. Subjects who took major surgery within the past 4 weeks in the 6months after kidney transplantation

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

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

ChulWoo Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chul-Woo Yang, MD

Role: PRINCIPAL_INVESTIGATOR

St Mary's Hospital, London

Locations

division of nephrology;Seoul St Mary's Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Chul Woo Yang

Role: primary

yangch@catholic.ac.kr

82-2-2258-6851

Other Identifiers

CRAD001AKR11T

Identifier Type: -

Identifier Source: org_study_id