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Double-blind, placebo-controlled clinical trial to determine the effect of Patiromer on vascular function and its relationship with mineral metabolism parameters

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503941-69-00
Acronym
PATIvasc
Enrollment
40
Registered
2023-07-24
Start date
2024-07-04
Completion date
2025-09-03
Last updated
2023-07-24

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

Conditions

Chronic kindney disease

Brief summary

Changes in indicators of arterial stiffness: pulse wave velocity and pulse pressure

Detailed description

Peripheral and central blood pressure., Biomarcadores del metabolismo mineral (fosfato sérico, calcio y magnesio, FGF23, vitamina D y PTH), 24-hour urinary excretion of phosphate, calcium, sodium, and potassium, Biomarkers of kidney damage: albumin/creatinine ratio, serum creatinine, eGFR, Endothelial function, Serum potassium concentration

Interventions

DRUGRLY5016 Placebo for Oral Suspension was developed for clinical trials and is intended to be administered orally
DRUGsuspended in water
DRUGapple juice or cranberry juice. The patients will be treated with either Placebo or with active drug product
DRUGRLY5016 for Oral Suspension. The Placebo was formulated using microcrystalline cellulose and xanthan gum to produce a powder blend that is packaged into 80 mm × 130 mm individual packets. For Placebo composition please refer to section 3.2.P.1 of IMPD

Sponsors

Fundacion Para La Investigacion Biomedica De Cordoba
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Changes in indicators of arterial stiffness: pulse wave velocity and pulse pressure

Secondary

MeasureTime frame
Peripheral and central blood pressure., Biomarcadores del metabolismo mineral (fosfato sérico, calcio y magnesio, FGF23, vitamina D y PTH), 24-hour urinary excretion of phosphate, calcium, sodium, and potassium, Biomarkers of kidney damage: albumin/creatinine ratio, serum creatinine, eGFR, Endothelial function, Serum potassium concentration

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026