Empagliflozin in Renal Transplant Recipients

Diabetes Mellitus Clinical Trial

— EMPA-RenalTx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157414
• Other study ID #: 2016/911
• Secondary ID: 2016-001705-1720
• Status: Completed
• Phase: Phase 4
• Start date: November 7, 2016
• Est. completion date: June 28, 2018

Study information

• Verified date: March 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Renal Insufficiency
• Safety Issues

Intervention

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

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of abnormal trough levels of immunosuppressive drugs	Trough levels of immunosuppressive drugs (tacrolimus); number of participants with abnormal laboratory values	24 weeks
Other	Adverse event	Recording of adverse events that are related to treatment	24 weeks
Other	Urinary glucose excretion	24 hour urine sampling at baseline and after 24 weeks to analyse change in urinary glucose excretion	24 weeks
Primary	Weighted mean glucose	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.	24 weeks
Secondary	Fasting plasma glucose	Change from baseline in fasting plasma glucose	24 weeks
Secondary	2 hour glucose concentration	Change from baseline in 2 hour glucose concentration after an oral glucose tolerance test	24 weeks
Secondary	Glycated hemoglobin (HbA1c)	Change from baseline in HbA1c	24 weeks
Secondary	Body weight	Change from baseline in body weight	24 weeks
Secondary	Waist-hip-ratio	Change from baseline in waist-hip-ratio	24 weeks
Secondary	Bone mineral density	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	24 weeks
Secondary	Body composition	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	24 weeks
Secondary	Blood pressure	Change from baseline in blood pressure, including orthostatic blood pressure	24 weeks
Secondary	Arterial stiffness	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	24 weeks
Secondary	Renal function	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	24 weeks