Treatment for proteinuria in type 1 or type 2 diabetes with hyperkalemia MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Lokelma
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Lokelma
Other descriptive name: SODIUM ZIRCONIUM CYCLOSILICATE
Concentration unit: g gram(s)
Concentration type
Sponsors
Steno Diabetes Center Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 180mmHg or persistent diastolic blood pressure >110 mm Hg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy (as assessed by reduction in urine albumin creatinine ratio) of Lokelma when compared to placebo in patients with type 1 or type 2 diabetes and nephropathy with hyperkalemia;Secondary Objective: To evaluate the change in eGFR during treatment with Lokelma when compared to placebo in patients with type 1 or type 2 diabetes and nephropathy with hyperkalemia. To evaluate whether treatment with Lokelma is associated with changes in 24h urinary sodium and potassium excretion ;Primary end point(s): Efficacy (as assessed by reduction in urine albumin creatinine ratio) of Lokelma compared to placebo.;Timepoint(s) of evaluation of this end point: At the beginning of the trial and after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the change in eGFR during treatment with Lokelma when compared to placebo in patients with type 1 and type 2 diabetes and nephropathy with hyperkalemia. To evaluate whether treatment with Lokelma is associated with changes in 24h urinary sodium and potassium excretion;Timepoint(s) of evaluation of this end point: At the beginning of the trial and after 12 weeks of treatment | — |
Countries
Denmark
Contacts
Public ContactKomplikationsforskningen
Steno Diabetes Center Copenhagen
Outcome results
None listed