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Trial record 43 of 1164 for:    MYCOPHENOLIC ACID

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

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ClinicalTrials.gov Identifier: NCT02036554
Recruitment Status : Unknown
Verified September 2014 by ChulWoo Yang, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : January 15, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
ChulWoo Yang, Seoul St. Mary's Hospital

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

Condition or disease Intervention/treatment Phase
Kidney; Complications, Allograft Drug: Everolimus Drug: Tacrolimus Drug: Mycophenolic acid Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: To Evaluate Prevention Effect 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
Study Start Date : March 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Tacrolimus plus Everolimus
Low dose Tacrolimus + Everolimus
Drug: Everolimus
Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
Other Name: Certican

Drug: Tacrolimus
Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
Other Name: Tacroli

Active Comparator: Tacrolimus plus Mycophenolic acid
standard dose Tacrolimus + Mycophenolic acid
Drug: Tacrolimus
Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
Other Name: Tacroli

Drug: Mycophenolic acid
Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
Other Name: Cellcept




Primary Outcome Measures :
  1. Change from Baseline in Development of NODAT (Fasting glucose ≥ 126 mg/dL, Random glucose ≥ 200 mg/dL) at 12 months [ Time Frame: 0 to 12 month ]
    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 at 12 months after date of randomization.


Secondary Outcome Measures :
  1. Insulin resistance by HOMA-IR [ Time Frame: 0 to 12 months ]
    Change from Baseline(V2) in Insulin resistance by HOMA-IR at 12months(V6)

  2. Insulin secretion by HOMA-beta [ Time Frame: 0 to 12 months ]
    Change from Baseline(V2) in insulin secretion by HOMA-beta at 12 months(V6)

  3. OGTT (Fasting and PP2hr) [ Time Frame: 0 to 12 months ]
    Change from baseline in OGTT (Fasting and PP2hr) at 12 months(V6)

  4. Needs for anti-diabetic medication or insulin [ Time Frame: at Baseline(V2) ]
    Needs for anti-diabetic medication or insulin at Baseline(V2)

  5. Needs for anti-diabetic medication or insulin at 3 month(V3) [ Time Frame: at 3 month(V3) ]
    Needs for anti-diabetic medication or insulin at 3 month(V3)

  6. Needs for anti-diabetic medication or insulin at 6 month(V4) [ Time Frame: at 6 month(V4) ]
    Needs for anti-diabetic medication or insulin at 6 month(V4)

  7. Needs for anti-diabetic medication or insulin at 9 month(V5) [ Time Frame: at 9 month(V5) ]
    Needs for anti-diabetic medication or insulin at 9 month(V5)

  8. Needs for anti-diabetic medication or insulin at 12 month(V6) [ Time Frame: at 12 month(V6) ]
    Needs for anti-diabetic medication or insulin at 12 month(V6)

  9. Creatinine clearance (MDRD eGFR) at Baseline(V2) [ Time Frame: at Baseline(V2) ]
    Creatinine clearance (MDRD eGFR) at Baseline(V2)

  10. Creatinine clearance (MDRD eGFR) at 3 month(V3) [ Time Frame: at 3 month(V3) ]
    Creatinine clearance (MDRD eGFR) at 3 month(V3)

  11. Creatinine clearance (MDRD eGFR) at 6 month(V4) [ Time Frame: at 6 month(V4) ]
    Creatinine clearance (MDRD eGFR) at 6 month(V4)

  12. Creatinine clearance (MDRD eGFR) at 9 month(V5) [ Time Frame: at 9 month(V5) ]
    Creatinine clearance (MDRD eGFR) at 9 month(V5)

  13. Creatinine clearance (MDRD eGFR) at 12 month(V6) [ Time Frame: at 12 month(V6) ]
    Creatinine clearance (MDRD eGFR) at 12 month(V6)

  14. 12 month graft survival [ Time Frame: at 12 months(V6) ]
    After date of randomization, evaluate graft survival rate at 12 months(V6)

  15. 12 month patient survival rate [ Time Frame: at 12 months(V6) ]
    After date of randomization, evaluate patient survival rate at 12 months(V6)

  16. Change from baseline in Microalbuminuria(MAU) at 12 months [ Time Frame: at 12 months(V6) ]
    Change from baseline in Microalbuminuria(MAU) at 12 months

  17. Proportion of patients with significant proteinuria greater than 1g/gCr at Baseline(V2) [ Time Frame: at Baseline(V2) ]
    Proportion of patients with significant proteinuria greater than 1g/gCr at Baseline(V2)

  18. Proportion of patients with significant proteinuria greater than 1g/gCr at 3 month(V3) [ Time Frame: at 3 month(V3) ]
    Proportion of patients with significant proteinuria greater than 1g/gCr at 3 month(V3)

  19. Proportion of patients with significant proteinuria greater than 1g/gCr at 6 month(V4) [ Time Frame: at 6 month(V4) ]
    Proportion of patients with significant proteinuria greater than 1g/gCr at 6 month(V4)

  20. Proportion of patients with significant proteinuria greater than 1g/gCr at 9 month(V5) [ Time Frame: at 9 month(V5) ]
    Proportion of patients with significant proteinuria greater than 1g/gCr at 9 month(V5)

  21. Proportion of patients with significant proteinuria greater than 1g/gCr at 12 month(V6) [ Time Frame: at 12 month(V6) ]
    Proportion of patients with significant proteinuria greater than 1g/gCr at 12 month(V6)

  22. Number of episode of biopsy proven acute rejection (BPAR) [ Time Frame: at 12 month(V6) ]
    Cumulative incidence rate of Biopsy Proven Acute Rejection(BPAR) at 12months(V6) after date of randomization.

  23. Number of hospitalization of any cause (except admission for protocol biopsy) at Baseline(V2) [ Time Frame: at Baseline(V2) ]
    Number of hospitalization of any cause (except admission for protocol biopsy) at Baseline(V2)

  24. Number of hospitalization of any cause (except admission for protocol biopsy) at 3 month(V3) [ Time Frame: at 3 month(V3) ]
    Number of hospitalization of any cause (except admission for protocol biopsy) at 3 month(V3)

  25. Number of hospitalization of any cause (except admission for protocol biopsy) at 6 month(V4) [ Time Frame: at 6 month(V4) ]
    Number of hospitalization of any cause (except admission for protocol biopsy) at 6 month(V4)

  26. Number of hospitalization of any cause (except admission for protocol biopsy) at 9 month(V5) [ Time Frame: at 9 month(V5) ]
    Number of hospitalization of any cause (except admission for protocol biopsy) at 9 month(V5)

  27. Number of hospitalization of any cause (except admission for protocol biopsy) at 12 month(V6) [ Time Frame: at 12 month(V6) ]
    Number of hospitalization of any cause (except admission for protocol biopsy) at 12 month(V6)

  28. Number of opportunistic infections (BKVN) at Baseline(V2) [ Time Frame: at Baseline(V2) ]
    Number of opportunistic infections (BKVN) at Baseline(V2)

  29. Number of opportunistic infections (BKVN) at 12month(V6) [ Time Frame: at 12 month(V6) ]
    Number of opportunistic infections (BKVN) at 12month(V6)

  30. Prevalence of NODAT at Baseline(V2) [ Time Frame: at Baseline(V2) ]
    Prevalence of NODAT at Baseline(V2)

  31. Prevalence of NODAT at 3 month(V3) [ Time Frame: at 3 month(V3) ]
    Prevalence of NODAT at 3 month(V3)

  32. Prevalence of NODAT at 6 month(V4) [ Time Frame: at 6 month(V4) ]
    Prevalence of NODAT at 6 month(V4)

  33. Prevalence of NODAT at 9 month (V5) [ Time Frame: at 9 month (V5) ]
    Prevalence of NODAT at 9 month (V5)

  34. Prevalence of NODAT at 12 month(V6) [ Time Frame: at 12 month(V6) ]
    Prevalence of NODAT at 12 month(V6)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036554


Locations
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Korea, Republic of
division of nephrology;Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chul Woo Yang    82-2-2258-6851    yangch@catholic.ac.kr   
Sponsors and Collaborators
Seoul St. Mary's Hospital
Novartis
Investigators
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Principal Investigator: Chul-Woo Yang, MD St Mary's Hospital, London

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Responsible Party: ChulWoo Yang, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02036554     History of Changes
Other Study ID Numbers: CRAD001AKR11T
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Mycophenolic Acid
Tacrolimus
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents