Effect of Lokelma on protein in the urine in persons with diabetes and elevated potassium

Phase 1

• Conditions: Treatment for proteinuria in type 1 or type 2 diabetes with hyperkalemia; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-000595-42-DK
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-28
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Provision of informed consent prior to any study specific procedures
2.Female and/or male patients with type 1 or type 2 diabetes aged 18-85 years
3.Persistent macroalbuminuria (UACR = 100 mg/g in at least two out of the three latest UACR measurements in subject history).
4.Chronic (at least 1 month) stable RAAS blocking treatment, i.e maximum tolerated (individually defined by investigator) dose of an ACE inhibitor or ARB at time of inclusion.
5.Documented hyperkalemia (plasma potassium = 5.0 mmol/l) at least once in the 90 days prior to inclusion in the study.
6.Negative pregnancy test (urine or serum) for female subjects of childbearing potential.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
2.Previous enrolment in the present study
3.Use of potassium-lowering agent (loop-diuretics not included)
4.Participation in another clinical study with an investigational product during the last 3 months prior to inclusion.
5.Plasma potassium < 3.0 mmol/l at any visit
6.Known hypersensitivity to Lokelma
7.Known history of drug or alcohol abuse within 1 year of screening
8.Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m2 (calculated by CKD-EPI formula).
9.Familiy history of long QT syndrome
10.For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
11.Persistent systolic blood pressure >180mmHg or persistent diastolic blood pressure >110 mm Hg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified