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Lokelma to Enable ACEIs/ARBs Use in the Treatment of Patients with Diabetic Kidney Disease

Lokelma to Enable ACEIs/ARBs Use in the Treatment of Patients with Diabetic Kidney Disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057589
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-02-28
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DKD

Interventions

Sodium zirconium cyclosilicate +ACEIs/ARBs combined administration group:Sodium zirconium cyclosilicate combined with ACEIs/ARBs was administered
ACEIs/ARBs alone treatment group:ACEIs/ARBs were treated separately

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in this protocol; 2. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses; 3. Subject must be >=18 years of age and 5.0 mmol/L) at least once in 90 days prior to inclusion in the study; 7. Patients took the ACEIs/ARBs (<= 50% maximum dose)before the enrollment.

Exclusion criteria

Exclusion criteria: 1. Presence of any conditions which, in the opinion of the investigator, places the participant at undue risk to be generated; 2. Patients with severe constipation, bowel obstruction or impaction; 3. Patients with renal artery stenosis, ketoacidosis or malignant arrhythmia; 4. Hypersensitivity to the active substance of Lokelma; 5. Pregnancy and lactation patients; 6. History of QT prolongation associated with other medications that required discontinuation of that medication; 7. Congenital long QT syndrome; 8. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted; 9. QTc(f) > 550 msec; 10. Patients with a pacemaker; 11. Those who have taken potassium-lowering resin and other potassium-lowering therapy within 7 days before informed consent; 12. In the opinion of the investigator, patient already with the highest tolerated doses of ACEIs/ARBs; 13. Has ever participated in current study before, or participating in any interventional study currently or during the last 3 months before informed consent.

Design outcomes

Primary

MeasureTime frame
Microalbuminuria/creatinine ratio;Serum biochemicals;Serum kalium;Routine blood indexes;Urine routine index;

Countries

China

Contacts

Public ContactWeiming Wang

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

wweiming01@126.com+86 13501657916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026