Empagliflozin in Renal Transplant Recipients (EMPA-RenalTx)

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus; Safety Issues; Renal Insufficiency

Treatments: Drug: Empagliflozin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03157414

2016069 (Other Grant/Funding Number)

2016-001705-17 (EudraCT Number)

2016/911

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups, including a placebo group

Empagliflozin

Active Comparator group

Description:

10 mg once daily for 24 weeks

Treatment:

Drug: Empagliflozin

Placebo

Placebo Comparator group

Description:

1 capsule once daily for 24 weeks

Treatment:

Other: Placebo