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Kidney Transplant; ComplicationsPhase 2CREST-KTNCT04906213

CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

A Phase 2 study testing Empagliflozin10Mg Tab in people with Kidney Transplant; Complications and Diabetes Mellitus, Type 2, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Empagliflozin10Mg Tab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
25 Jul 2022to 22 Jan 2026
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 -

Who cannot join

  • 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
Show all 12Show fewer
  • 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 -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read the detailed description

A screening visit will occur at which time an informed consent will be obtained, and eligibility determined. Women of childbearing potential will have a serum pregnancy test performed. This will be followed by a baseline visit. A renal biopsy and a 3D echocardiogram will be performed. At the next visit randomization will be performed and the subjects will receive their study medication, either empagliflozin or a placebo. Following the randomization visit the subject will return every 3 months (visits 2-7) for a total of 6 visits spanning 18 months. At each visit vital signs and weight will be taken. Other procedures include labs drawn for hematology, basic chemistry, coagulation, Glycated hemoglobin and serum insulin. A 3 D echocardiogram is repeated on Visits 4 and 6. A renal biopsy is repeated on Visit 3.

Being tested
Empagliflozin10Mg Tab, Placebo
Keywords
Post operative kidney transplant
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Empagliflozin10Mg TabDrug

    Empagliflozin10 Mg daily or placebo daily for 18 months

  • PlaceboDrug

    10Mg Placebo Tab

Study groups in NCT04906213
Study groupRoleWhat they receive
Arm I: With Type II DiabetesActive comparatorKidney Transplant recipient with Type II diabetes, randomized to either Empagliflozin or a placebo.
Receives: Drug: Empagliflozin10Mg Tab; Drug: Placebo
Arm 2: Without DiabetesActive comparatorKidney Transplant recipient without Type II diabetes, randomized to either Empagliflozin or a placebo
Receives: Drug: Empagliflozin10Mg Tab; Drug: Placebo

What is being measured

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

  1. Change in kidney function as measured by eGFR

    eGFR will be measured by blood test

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

  2. Change in kidney function as measured by albuminuria

    Albuminuria will be measured by urine Albumin/Creatinine Ratio

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

  3. Change in cardiac structure

    Cardiac structure as measured by the 3D echocardiogram

    Measured: Baseline, month 9 and month15

  4. Change in blood insulin level

    Blood insulin level will be determined lab values

    Measured: Baseline, month 6 and month 18

  5. Change in fasting blood sugar

    Fasting Blood sugar will be determined lab values

    Measured: Baseline, month 6 and month 18

  6. Number of Urinary Tract infections

    Data to be gathered from chart review and patient report

    Measured: up to 18 months

  7. Number of Genital infections

    Data to be gathered from chart review and patient report

    Measured: up to 18 months

Secondary outcomes (2)

  1. Change in kidney biopsy as measured by percentage of interstitial fibrosis

    Measured: Baseline and 6 months

  2. Changes in Hemoglobin A1C as measured by blood work

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

Timeline

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

  1. First posted28 May 2021
  2. Study start25 Jul 2022
  3. Primary completion22 Jan 2026
  4. Study completion22 Jan 2026

Why it stopped: The study closed per PI decision due to completion of the biopsy substudy and slow accrual

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Placebo-controlled, double-blind, randomized clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04906213
Sponsor's protocol ID
Pro00107752
Acronym
CREST-KT
Status last verified
Jan 2026
First submitted
18 May 2021
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual data will not be shared

Publications

  • 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.

    PubMed 25081992

  • 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.

    PubMed 26981940

  • 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.

    PubMed 28605608

  • 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.

    PubMed 30415602

  • 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.

    PubMed 30862658

  • 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.

    PubMed 27470878

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Empagliflozin10Mg Tab in people with Kidney Transplant; Complications and Diabetes Mellitus, Type 2, run by Duke University at 1 site in United States.

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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 27 Feb 2026. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was stopped early (reason given: The study closed per PI decision due to completion of the biopsy substudy and slow accrual). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in kidney function as measured by eGFR (time frame: Baseline, 6 months, 9 months, 12 months and 18 months). The study lists 7 primary outcomes in all. 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 NCT04906213, which also lists 6 linked publications.

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 27 Feb 2026.

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