NCT04906213

Brief Summary

CREST-KT is a single-center, double-blinded, randomized trial of empagliflozin therapy in 72 kidney transplant recipients with (n=36) and without type 2 diabetes (n=36). After evenly dividing patients by type 2 diabetes diagnosis, patients will be randomized 2:1 to empagliflozin 10mg versus placebo.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2026

Completed
Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

May 18, 2021

Last Update Submit

February 26, 2026

Conditions

Kidney Transplant; ComplicationsDiabetes Mellitus, Type 2

Keywords

Post operative kidney transplant

Outcome Measures

Primary Outcomes (7)

  • Change in kidney function as measured by eGFR

    eGFR will be measured by blood test

    Baseline, 6 months, 9 months, 12 months and 18 months

  • Change in kidney function as measured by albuminuria

    Albuminuria will be measured by urine Albumin/Creatinine Ratio

    Baseline, 6 months, 9 months, 12 months and 18 months

  • Change in cardiac structure

    Cardiac structure as measured by the 3D echocardiogram

    Baseline, month 9 and month15

  • Change in blood insulin level

    Blood insulin level will be determined lab values

    Baseline, month 6 and month 18

  • Change in fasting blood sugar

    Fasting Blood sugar will be determined lab values

    Baseline, month 6 and month 18

  • Number of Urinary Tract infections

    Data to be gathered from chart review and patient report

    up to 18 months

  • Number of Genital infections

    Data to be gathered from chart review and patient report

    up to 18 months

Secondary Outcomes (2)

  • Change in kidney biopsy as measured by percentage of interstitial fibrosis

    Baseline and 6 months

  • Changes in Hemoglobin A1C as measured by blood work

    Baseline, Months 3,6,9,12,15 and 18

Other Outcomes (1)

  • Adverse events will be collected form the medical record and patient report

    up to 18 months

Study Arms (2)

Arm I: With Type II Diabetes

ACTIVE COMPARATOR

Kidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.

Drug: Empagliflozin10Mg TabDrug: Placebo

Arm 2: Without Diabetes

ACTIVE COMPARATOR

Kidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo

Drug: Empagliflozin10Mg TabDrug: Placebo

Interventions

Empagliflozin10Mg TabDRUG

Empagliflozin10 Mg daily or placebo daily for 18 months

Arm 2: Without DiabetesArm I: With Type II Diabetes
PlaceboDRUG

10Mg Placebo Tab

Arm 2: Without DiabetesArm I: With Type II Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Equal to or greater than 12 months and up tp 60 months post kidney transplant
  • Estimated glomerular filtration rate (eGFR) equal to or greater than 30ml/min/1.73m squared at screening
  • Standard immunosuppression, including calcineurin inhibitor, Mycophenolate Mofetil or Sodium and a glucocorticoid
  • Able to provide written consent -

You may not qualify if:

  • Type I diabetes
  • Any other solid organ transplant
  • Hemoglobin A1c greater than 12 %
  • SGLT2i use at the time of enrollment
  • Prior SGLT2i allergy or intolerance
  • Pregnant or nursing at the time of enrollment
  • History of antibody medicated rejection (AMR) or a Banff score greater than 2B for acute cellular rejection (ACR)
  • Active anticoagulant use other than aspirin 81 mg for primary prevention of cardiovascular disease
  • Known positive donor-specific antibodies prior to enrollment
  • Uncircumcised men
  • Greater than 2 urinary tract infections (UTI) over the 12 months prior to enrollment
  • Any genital infections over the 12 months prior to enrollment -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (6)

  • Stoumpos S, Jardine AG, Mark PB. Cardiovascular morbidity and mortality after kidney transplantation. Transpl Int. 2015 Jan;28(1):10-21. doi: 10.1111/tri.12413. Epub 2014 Aug 20.

    PMID: 25081992RESULT

  • Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1094. doi: 10.1056/NEJMc1600827. No abstract available.

    PMID: 26981940RESULT

  • Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.

    PMID: 28605608RESULT

  • Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.

    PMID: 30415602RESULT

  • Halden TAS, Kvitne KE, Midtvedt K, Rajakumar L, Robertsen I, Brox J, Bollerslev J, Hartmann A, Asberg A, Jenssen T. Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Posttransplant Diabetes Mellitus. Diabetes Care. 2019 Jun;42(6):1067-1074. doi: 10.2337/dc19-0093. Epub 2019 Mar 12.

    PMID: 30862658RESULT

  • Heerspink HJ, Perkins BA, Fitchett DH, Husain M, Cherney DZ. Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Diabetes Mellitus: Cardiovascular and Kidney Effects, Potential Mechanisms, and Clinical Applications. Circulation. 2016 Sep 6;134(10):752-72. doi: 10.1161/CIRCULATIONAHA.116.021887. Epub 2016 Jul 28.

    PMID: 27470878RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Myles Wolf, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Placebo-controlled, double-blind, randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 28, 2021

Study Start

July 25, 2022

Primary Completion

January 22, 2026

Study Completion

January 22, 2026

Last Updated

February 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual data will not be shared

Locations

US(1)