NCT02036554

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
234

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2.8 years

First QC Date

December 23, 2013

Last Update Submit

September 22, 2014

Conditions

Kidney; Complications, Allograft

Outcome Measures

Primary Outcomes (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.

    0 to 12 month

Secondary Outcomes (34)

  • Insulin resistance by HOMA-IR

    0 to 12 months

  • Insulin secretion by HOMA-beta

    0 to 12 months

  • OGTT (Fasting and PP2hr)

    0 to 12 months

  • Needs for anti-diabetic medication or insulin

    at Baseline(V2)

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

    at 3 month(V3)

  • +29 more secondary outcomes

Study Arms (2)

Tacrolimus plus Everolimus

EXPERIMENTAL

Low dose Tacrolimus + Everolimus

Drug: EverolimusDrug: Tacrolimus

Tacrolimus plus Mycophenolic acid

ACTIVE COMPARATOR

standard dose Tacrolimus + Mycophenolic acid

Drug: TacrolimusDrug: Mycophenolic acid

Interventions

EverolimusDRUG

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

Also known as: Certican
Tacrolimus plus Everolimus
TacrolimusDRUG

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

Also known as: Tacroli
Tacrolimus plus EverolimusTacrolimus plus Mycophenolic acid
Mycophenolic acidDRUG

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

Also known as: Cellcept
Tacrolimus plus Mycophenolic acid

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Subjects who received combined non-renal transplantation
  • Subject who received re-transplantation
  • Sensitized patients before transplantation
  • Pretransplant or peak PRA titer \> 50%
  • Pretransplant T cell cytotoxicity crossmatch (+)
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

division of nephrology;Seoul St Mary's Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

EverolimusTacrolimusMycophenolic Acid

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Chul-Woo Yang, MD

    St Mary's Hospital, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 23, 2013

First Posted

January 15, 2014

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

KR(1)