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

September 22, 2014 updated by: ChulWoo Yang, Seoul St. Mary's Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Certican
Drug: Tacrolimus
Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
Other Names:
  • 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 Names:
  • Tacroli
Drug: Mycophenolic acid
Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
Other Names:
  • Cellcept

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0 to 12 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin resistance by HOMA-IR
Time Frame: 0 to 12 months
Change from Baseline(V2) in Insulin resistance by HOMA-IR at 12months(V6)
0 to 12 months
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)
0 to 12 months
OGTT (Fasting and PP2hr)
Time Frame: 0 to 12 months
Change from baseline in OGTT (Fasting and PP2hr) at 12 months(V6)
0 to 12 months
Needs for anti-diabetic medication or insulin
Time Frame: at Baseline(V2)
Needs for anti-diabetic medication or insulin at Baseline(V2)
at Baseline(V2)
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)
at 3 month(V3)
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)
at 6 month(V4)
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)
at 9 month(V5)
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)
at 12 month(V6)
Creatinine clearance (MDRD eGFR) at Baseline(V2)
Time Frame: at Baseline(V2)
Creatinine clearance (MDRD eGFR) at Baseline(V2)
at Baseline(V2)
Creatinine clearance (MDRD eGFR) at 3 month(V3)
Time Frame: at 3 month(V3)
Creatinine clearance (MDRD eGFR) at 3 month(V3)
at 3 month(V3)
Creatinine clearance (MDRD eGFR) at 6 month(V4)
Time Frame: at 6 month(V4)
Creatinine clearance (MDRD eGFR) at 6 month(V4)
at 6 month(V4)
Creatinine clearance (MDRD eGFR) at 9 month(V5)
Time Frame: at 9 month(V5)
Creatinine clearance (MDRD eGFR) at 9 month(V5)
at 9 month(V5)
Creatinine clearance (MDRD eGFR) at 12 month(V6)
Time Frame: at 12 month(V6)
Creatinine clearance (MDRD eGFR) at 12 month(V6)
at 12 month(V6)
12 month graft survival
Time Frame: at 12 months(V6)
After date of randomization, evaluate graft survival rate at 12 months(V6)
at 12 months(V6)
12 month patient survival rate
Time Frame: at 12 months(V6)
After date of randomization, evaluate patient survival rate at 12 months(V6)
at 12 months(V6)
Change from baseline in Microalbuminuria(MAU) at 12 months
Time Frame: at 12 months(V6)
Change from baseline in Microalbuminuria(MAU) at 12 months
at 12 months(V6)
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)
at Baseline(V2)
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)
at 3 month(V3)
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)
at 6 month(V4)
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)
at 9 month(V5)
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)
at 12 month(V6)
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.
at 12 month(V6)
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)
at Baseline(V2)
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)
at 3 month(V3)
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)
at 6 month(V4)
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)
at 9 month(V5)
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)
at 12 month(V6)
Number of opportunistic infections (BKVN) at Baseline(V2)
Time Frame: at Baseline(V2)
Number of opportunistic infections (BKVN) at Baseline(V2)
at Baseline(V2)
Number of opportunistic infections (BKVN) at 12month(V6)
Time Frame: at 12 month(V6)
Number of opportunistic infections (BKVN) at 12month(V6)
at 12 month(V6)
Prevalence of NODAT at Baseline(V2)
Time Frame: at Baseline(V2)
Prevalence of NODAT at Baseline(V2)
at Baseline(V2)
Prevalence of NODAT at 3 month(V3)
Time Frame: at 3 month(V3)
Prevalence of NODAT at 3 month(V3)
at 3 month(V3)
Prevalence of NODAT at 6 month(V4)
Time Frame: at 6 month(V4)
Prevalence of NODAT at 6 month(V4)
at 6 month(V4)
Prevalence of NODAT at 9 month (V5)
Time Frame: at 9 month (V5)
Prevalence of NODAT at 9 month (V5)
at 9 month (V5)
Prevalence of NODAT at 12 month(V6)
Time Frame: at 12 month(V6)
Prevalence of NODAT at 12 month(V6)
at 12 month(V6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul St. Mary's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chul-Woo Yang, MD, St Mary's Hospital, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRAD001AKR11T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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