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NCT Number: NCT03157414

Empagliflozin in Renal Transplant Recipients

This is a single-center, prospective, controlled, double-blind, randomized study. A total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM) will be included more than 1 year after transplantation and randomized 1:1 to empagliflozin (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at baseline and after 24 weeks in addition to standard safety measurements. Two safety visits will be performed at week 8 and 16. All concomitant medication, diet and exercise will be kept stable during the study period. The objective of the present study is to answer whether empagliflozin safely and effectively improves glucose metabolism together with weight loss in renal transplant recipients with PTDM.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Safety Issues Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oslo University Hospital Rikshospitalet

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Renal transplant recipient transplanted more than 1 year ago
  • Stable renal function (<20% deviation in serum creatinine within last 2 months)
  • Stable immunosuppressive therapy ≥3 months before inclusion
  • Diagnosed with PTDM:

(fasting plasma glucose ≥7.0 mmol/l and/or 2-hour plasma glucose ≥11.1 mmol/l following an oral glucose tolerance test)

-Signed informed consent and expected cooperation of the patients

Exclusion criteria

  • Estimated GFR <30 ml/min/1.73 m2
  • Pregnant or nursing mothers
  • Hypersensitivity to the active substance (IMP) or to any of the excipients
  • Any reason why, in the opinion of the investigator, the patient should not participate

Treatment and study plan

Empagliflozin

Drug

Empagliflozin tablets enclosed with red capsules (Capsugel AAEL) by Kragerø Tablettproduksjon AS for blinding purpose

Other names: Jardiance

Placebo

Other

Placebo tablets made by Kragerø Tablettproduksjon AS and enclosed with red capsules (Capsugel AAEL) for blinding purpose

Primary outcomes

  1. Weighted mean glucose

    Time frame: 24 weeks

    The primary endpoint will be change from baseline in weighted mean glucose at week 24 compared to placebo. Each patient will perform continuous plasma glucose monitoring (CGM, iProTM2) for 72 hours at baseline and after 24 weeks.

Secondary outcomes

  1. Fasting plasma glucose

    Time frame: 24 weeks

    Change from baseline in fasting plasma glucose

  2. 2 hour glucose concentration

    Time frame: 24 weeks

    Change from baseline in 2 hour glucose concentration after an oral glucose tolerance test

  3. Glycated hemoglobin (HbA1c)

    Time frame: 24 weeks

    Change from baseline in HbA1c

  4. Body weight

    Time frame: 24 weeks

    Change from baseline in body weight

  5. Waist-hip-ratio

    Time frame: 24 weeks

    Change from baseline in waist-hip-ratio

  6. Bone mineral density

    Time frame: 24 weeks

    Measurement of bone mineral density, using low dosage radiation (dual-energy X-ray absorptiometry (DEXA) scan) to assess the amount (grams) of mineral that are packed into a segment of bone

  7. Body composition

    Time frame: 24 weeks

    Body composition (visceral fat, metabolic measurement) will be determined using the software CoreScan (encore version 14.10, GE Healthcare) on the DEXA scans. This will allow us to analyze changes in body fat compartments to explain overall weight reduction

  8. Blood pressure

    Time frame: 24 weeks

    Change from baseline in blood pressure, including orthostatic blood pressure

  9. Arterial stiffness

    Time frame: 24 weeks

    Pulse wave velocity, using a SphygmoCor device, measuring arterial stiffness will be performed in addition to pulse wave analysis evaluating the shape and amplitude of the aortic pulse wave

  10. Renal function

    Time frame: 24 weeks

    Renal function, defined as glomerular filtration rate (GFR), will be evaluated by creatinine and cystatin C-based estimated GFR using the chronic kidney disease epidemiology collaboration (CKD-EPI) formula. Fasting plasma creatinine and Cystatin C will be drawn at the same time and analyses will be performed at the Hospital central laboratory

Other outcomes

  1. Incidence of abnormal trough levels of immunosuppressive drugs

    Time frame: 24 weeks

    Trough levels of immunosuppressive drugs (tacrolimus); number of participants with abnormal laboratory values

  2. Adverse event

    Time frame: 24 weeks

    Recording of adverse events that are related to treatment

  3. Urinary glucose excretion

    Time frame: 24 weeks

    24 hour urine sampling at baseline and after 24 weeks to analyse change in urinary glucose excretion

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Post-transplantation Diabetes Mellitus

Acronym: EMPA-RenalTx

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 17, 2017
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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