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Trial record 30 of 187 for:    BI10773

Empagliflozin in Renal Transplant Recipients (EMPA-RenalTx)

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ClinicalTrials.gov Identifier: NCT03157414
Recruitment Status : Active, not recruiting
First Posted : May 17, 2017
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Trond Jenssen, Oslo University Hospital

Brief Summary:
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 radomized 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Renal Insufficiency Safety Issues Drug: Empagliflozin Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Post-transplantation Diabetes Mellitus
Actual Study Start Date : November 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Empagliflozin
10 mg once daily for 24 weeks
Drug: Empagliflozin
Empagliflozin tablets enclosed with red capsules (Capsugel AAEL) by Kragerø Tablettproduksjon AS for blinding purpose
Other Name: Jardiance

Placebo Comparator: Placebo
1 capsule once daily for 24 weeks
Other: Placebo
Placebo tablets made by Kragerø Tablettproduksjon AS and enclosed with red capsules (Capsugel AAEL) for blinding purpose




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157414


Locations
Norway
Oslo University Hospital Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital

Responsible Party: Trond Jenssen, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03157414     History of Changes
Other Study ID Numbers: 2016/911
2016-001705-17 ( EudraCT Number )
2016069 ( Other Grant/Funding Number: South-Eastern Norway Regional Health Authority )
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs