The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia

NCT04063930 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 2019-000595-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.

Conditions

Type 2 Diabetes Mellitus With Kidney Complications

Keywords

Hyperkalemia; Renin angiotensin system

Outcome Measures

Primary Outcomes (1)

• Urinary albumin creatinine ratio (UACR)

  Change in the geometric mean of UACR (milligram per gram) measured in three consecutive morning spot urine collections from baseline to end of treatment

  12 weeks

Secondary Outcomes (3)

• Estimated glomerular filtration rate (eGFR)

  12 weeks

• Urinary sodium

  12 weeks

• Urinary potassium

  12 weeks

Other Outcomes (2)

• Safety outcome - Adverse events

  12 weeks

• Safety outcome - Electrocardiogram

  12 weeks

Study Arms (2)

Lokelma

ACTIVE COMPARATOR

Sodium zirconium cyclosilicate Lokelma® 5 g, powder (Astra Zeneca) After initial dosing subjects will be instructed to take the study drug once daily in the morning, by oral administration after the powder has been dissolved in a glass of drinking water. Duration: 12 weeks

Drug: LOKELMA 5 GM Powder for Oral Suspension

Placebo

PLACEBO COMPARATOR

Matching placebo (indistinguishable from the active comparator) After initial dosing subjects will be instructed to take the study drug once daily in the morning, by oral administration after the powder has been dissolved in a glass of drinking water. Duration: 12 weeks

Drug: Placebos

Interventions

LOKELMA 5 GM Powder for Oral Suspension DRUG

Sodium zirconium cyclosilicate (a hyperkalemia treatment)

Lokelma

Placebos DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Female and/or male patients with type 2 diabetes aged 18-85 years
• Persistent macroalbuminuria (UACR ≥ 200 mg/g in at least two out of the three latest UACR measurements in subject history).
• Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
• Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of Lokelma/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
• Previous enrolment in the present study
• Use of potassium-lowering agent (loop-diuretics not included)
• Known hypersensitivity to Lokelma
• Known history of drug or alcohol abuse within 1 year of screening
• Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 (calculated by CKD-EPI formula).
• History of long QT syndrome.
• For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• AstraZeneca: collaborator
• Zealand University Hospital: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

RECRUITING

MeSH Terms

Conditions

Hyperkalemia

Interventions

Suspensions

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Peter Rossing, Professor

CONTACT

0045 30913383; peter.rossing@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 21, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)