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Kidney; Complications, AllograftPhase 4PROTECTNCT02036554

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

A Phase 4 study testing Everolimus, Tacrolimus and Mycophenolic acid in people with Kidney; Complications, Allograft, run by Seoul St. Mary's Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Kidney; Complications, Allograft
What is being tested?
Everolimus, Tacrolimus and Mycophenolic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
1 siteSouth Korea
Study dates
Mar 2013to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 20 year old
  • At least 3 months after kidney transplantation
  • Subject who is using Tacrolimus ± purine synthesis inhibitor + steroid without change within the past 3 months (except the dosage)
  • MDRD eGFR ≥ 50 mL/min or serum creatinine < 2.0mg/dL within the past 3 months in the 6months after kidney transplantation
  • 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.)
  • Urine protein/creatinine ratio < 1g/g Cr (spot urine) Subject who is not applicable to the diagnostic criteria NODAT on
  • the baseline in the 6months after kidney transplantation
  • Subjects who agree with written informed consent

Who cannot join

  • Subjects who received combined non-renal transplantation
  • Subject who received re-transplantation
  • ABO blood group incompatible(when anti-ABO Antibody titer <1:128 is inclusion possible.)
  • Sensitized patients before transplantation
  • Pretransplant or peak PRA titer > 50%
  • Pretransplant T cell cytotoxicity crossmatch (+)
Show all 21Show fewer
  • HLA-identical living related donor
  • Subject who has diabetes mellitus / NODAT before transplantation
  • Subject who has suffered acute rejection episode within the past 3 months in the 6months after kidney transplantation
  • Subject with hypersensitivity to everolimus
  • Subject who should continue nephrotoxic drug until enrollment (Aminoglycoside, amphotericin B, cisplatin)
  • Subject with GI disorder that might interfere with the ability to absorb oral medication. (eg, gastrectomy or insufficiently treated diabetic gastroenteropathy)
  • Subjects with active peptic ulcer
  • HIV, HBsAg, or HCV Ab tests (+)
  • Abnormal liver function test (AST or ALT or total bilirubin> upper normal limit x3)
  • ANC <1.5*109/L or WBC <2.5*109/L or platelet <75*109/L
  • Treatment with an investigational drug within 30 days preceding the first dose of trial medication
  • Women who are either pregnant, lactating, planning to become pregnant in the next 12 months.
  • Subjects with history of cancer(except successfully treated), localized nonmelanocytic skin cancer, PTLD(Post-transplant lymphoproliferative disorder)
  • Subjects with clinically significant infections within the past 4 weeks in the 6months after kidney transplantation
  • Subjects who took major surgery within the past 4 weeks in the 6months after kidney transplantation

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • division of nephrology;Seoul St Mary's Hospital

    Seoul

    Chul Woo Yang, 82-2-2258-6851, yangch@catholic.ac.kr

    Recruiting

Other trials in South Korea

About this study

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

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

Read the 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

Being tested
Everolimus, Tacrolimus, Mycophenolic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Also called Certican

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

  • TacrolimusDrug

    Also called Tacroli

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

  • Mycophenolic acidDrug

    Also called Cellcept

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

Study groups in NCT02036554
Study groupRoleWhat they receive
Tacrolimus plus EverolimusExperimentalLow dose Tacrolimus + Everolimus
Receives: Drug: Everolimus; Drug: Tacrolimus
Tacrolimus plus Mycophenolic acidActive comparatorstandard dose Tacrolimus + Mycophenolic acid
Receives: Drug: Tacrolimus; Drug: Mycophenolic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Development of NODAT (Fasting glucose ≥ 126 mg/dL, Random glucose ≥ 200 mg/dL) at 12 months

    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.

    Measured: 0 to 12 month

Secondary outcomes (34)

  1. Insulin resistance by HOMA-IR

    Change from Baseline(V2) in Insulin resistance by HOMA-IR at 12months(V6)

    Measured: 0 to 12 months

  2. Insulin secretion by HOMA-beta

    Change from Baseline(V2) in insulin secretion by HOMA-beta at 12 months(V6)

    Measured: 0 to 12 months

  3. OGTT (Fasting and PP2hr)

    Change from baseline in OGTT (Fasting and PP2hr) at 12 months(V6)

    Measured: 0 to 12 months

  4. Needs for anti-diabetic medication or insulin

    Needs for anti-diabetic medication or insulin at Baseline(V2)

    Measured: at Baseline(V2)

  5. Needs for anti-diabetic medication or insulin at 3 month(V3)

    Needs for anti-diabetic medication or insulin at 3 month(V3)

    Measured: at 3 month(V3)

  6. Needs for anti-diabetic medication or insulin at 6 month(V4)

    Needs for anti-diabetic medication or insulin at 6 month(V4)

    Measured: at 6 month(V4)

  7. Needs for anti-diabetic medication or insulin at 9 month(V5)

    Needs for anti-diabetic medication or insulin at 9 month(V5)

    Measured: at 9 month(V5)

  8. Needs for anti-diabetic medication or insulin at 12 month(V6)

    Needs for anti-diabetic medication or insulin at 12 month(V6)

    Measured: at 12 month(V6)

  9. Creatinine clearance (MDRD eGFR) at Baseline(V2)

    Creatinine clearance (MDRD eGFR) at Baseline(V2)

    Measured: at Baseline(V2)

  10. Creatinine clearance (MDRD eGFR) at 3 month(V3)

    Creatinine clearance (MDRD eGFR) at 3 month(V3)

    Measured: at 3 month(V3)

  11. Creatinine clearance (MDRD eGFR) at 6 month(V4)

    Creatinine clearance (MDRD eGFR) at 6 month(V4)

    Measured: at 6 month(V4)

  12. Creatinine clearance (MDRD eGFR) at 9 month(V5)

    Creatinine clearance (MDRD eGFR) at 9 month(V5)

    Measured: at 9 month(V5)

  13. Creatinine clearance (MDRD eGFR) at 12 month(V6)

    Creatinine clearance (MDRD eGFR) at 12 month(V6)

    Measured: at 12 month(V6)

  14. 12 month graft survival

    After date of randomization, evaluate graft survival rate at 12 months(V6)

    Measured: at 12 months(V6)

  15. 12 month patient survival rate

    After date of randomization, evaluate patient survival rate at 12 months(V6)

    Measured: at 12 months(V6)

  16. Change from baseline in Microalbuminuria(MAU) at 12 months

    Change from baseline in Microalbuminuria(MAU) at 12 months

    Measured: at 12 months(V6)

  17. Proportion of patients with significant proteinuria greater than 1g/gCr at Baseline(V2)

    Proportion of patients with significant proteinuria greater than 1g/gCr at Baseline(V2)

    Measured: at Baseline(V2)

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

    Proportion of patients with significant proteinuria greater than 1g/gCr at 3 month(V3)

    Measured: at 3 month(V3)

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

    Proportion of patients with significant proteinuria greater than 1g/gCr at 6 month(V4)

    Measured: at 6 month(V4)

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

    Proportion of patients with significant proteinuria greater than 1g/gCr at 9 month(V5)

    Measured: at 9 month(V5)

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

    Proportion of patients with significant proteinuria greater than 1g/gCr at 12 month(V6)

    Measured: at 12 month(V6)

  22. Number of episode of biopsy proven acute rejection (BPAR)

    Cumulative incidence rate of Biopsy Proven Acute Rejection(BPAR) at 12months(V6) after date of randomization.

    Measured: at 12 month(V6)

  23. Number of hospitalization of any cause (except admission for protocol biopsy) at Baseline(V2)

    Number of hospitalization of any cause (except admission for protocol biopsy) at Baseline(V2)

    Measured: at Baseline(V2)

  24. Number of hospitalization of any cause (except admission for protocol biopsy) at 3 month(V3)

    Number of hospitalization of any cause (except admission for protocol biopsy) at 3 month(V3)

    Measured: at 3 month(V3)

  25. Number of hospitalization of any cause (except admission for protocol biopsy) at 6 month(V4)

    Number of hospitalization of any cause (except admission for protocol biopsy) at 6 month(V4)

    Measured: at 6 month(V4)

  26. Number of hospitalization of any cause (except admission for protocol biopsy) at 9 month(V5)

    Number of hospitalization of any cause (except admission for protocol biopsy) at 9 month(V5)

    Measured: at 9 month(V5)

  27. Number of hospitalization of any cause (except admission for protocol biopsy) at 12 month(V6)

    Number of hospitalization of any cause (except admission for protocol biopsy) at 12 month(V6)

    Measured: at 12 month(V6)

  28. Number of opportunistic infections (BKVN) at Baseline(V2)

    Number of opportunistic infections (BKVN) at Baseline(V2)

    Measured: at Baseline(V2)

  29. Number of opportunistic infections (BKVN) at 12month(V6)

    Number of opportunistic infections (BKVN) at 12month(V6)

    Measured: at 12 month(V6)

  30. Prevalence of NODAT at Baseline(V2)

    Prevalence of NODAT at Baseline(V2)

    Measured: at Baseline(V2)

  31. Prevalence of NODAT at 3 month(V3)

    Prevalence of NODAT at 3 month(V3)

    Measured: at 3 month(V3)

  32. Prevalence of NODAT at 6 month(V4)

    Prevalence of NODAT at 6 month(V4)

    Measured: at 6 month(V4)

  33. Prevalence of NODAT at 9 month (V5)

    Prevalence of NODAT at 9 month (V5)

    Measured: at 9 month (V5)

  34. Prevalence of NODAT at 12 month(V6)

    Prevalence of NODAT at 12 month(V6)

    Measured: at 12 month(V6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2014 (estimated)
  2. Study startMar 2013
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02036554
Sponsor's protocol ID
CRAD001AKR11T
Acronym
PROTECT
Status last verified
Sep 2014
First submitted
23 Dec 2013
Last updated
25 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Everolimus, Tacrolimus and Mycophenolic acid in people with Kidney; Complications, Allograft, run by Seoul St. Mary's Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02036554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.

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