Phase III, Multicenter, Open-label, Randomized Clinical Trial to Evaluate Efficacy of Sodium Zirconium Cyclosilicate (Lokelma) Compared to Standard of Care to Manage Hyperkalemia in Patients With Chronic Kidney Disease (CKD)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation/reduction and/or ARM (standard treatment).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must present serum potassium levels of 5.5-6.5 mEq/L at patient selection visit (V0)

• Patients must present serum potassium levels of 5.0-6.5 mEq/L at randomization visit (V1).

• Provision of patient or legal representative informed consent prior to any study specific procedures.

• Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include RAASi and/or MRA treatment at first consultation and at least should have been stable for ≥ 4 weeks at maximum tolerated doses.

• Patients with CKD not on dialysis (Stages 2-5: estimated glomerular filtration rate (eGFR) between 15-60 ml/min/1,73m2 or eGFR between 60-90 ml/min/ 1.73 m2 with albuminuria/creatinuria (\> 30 mg/g) in the previous three months). The estimated GFR can be reported by the laboratory or calculated by the researcher with serum creatinine, age, and sex (CKD-EPI equation).

• 18 years at the time of signing ICF.

• 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 ICF) and for 3 months after the last dose of SZC. 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.

Locations
Other Locations
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Universitario Vall d'Hebrón
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario Doctor Peset
RECRUITING
Valencia
Contact Information
Primary
Jose Luis Górriz
jlgorriz@gmail.com
+34 96 197 38 11
Time Frame
Start Date: 2022-09-30
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 78
Treatments
No_intervention: Control group
Patients assigned to this group will have their iSRAA and/or ARM treatment withdrawn or reduced, according to standard clinical practice.
Experimental: Experimental group
Patients assigned to this group will be maintained on treatment with iSRAA and/or ARM and oral treatment with CSZ (Lokelma) will be added. A single dose of CSZ consists of one to three sachets (5 to 10 g of active ingredient per sachet) that the subject must suspend in 45 mL of water.
Related Therapeutic Areas
Sponsors
Leads: Fundación para la Investigación del Hospital Clínico de Valencia

This content was sourced from clinicaltrials.gov

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