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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica De Cordoba

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

4 Jul 2024 → 3 Sep 2025

Decision date (initial)

2023-07-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Vifor Fresenius Medical Care Renal Pharma España SL

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine the effect of treatment with patiromer on vascular function and mineral metabolism in patients with CKD

Secondary objectives 4

1. To assess the effect of patiromer on arterial stiffness
2. To assess the effect of patiromer on blood pressure
3. To assess the effect of patiromer on endothelial function
4. To assess the effect of patiromer on biomarkers of mineral-bone metabolism

Conditions and MedDRA coding

Chronic kindney disease

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 18 years and older of both sexes.
2. Chronic kidney disease, defined by an eGFR 15-60 ml/min/1.73m2 estimated using the CKD-EPI equation
3. Potassium levels between 5 and 6 mEq/L in at least 2 of 4 previous blood test results and potassium level between 5 and 6 mEq/L at screening visit
4. Must be on ACEI or ARB or aldosterone antagonist therapy for at least one month prior to screening at the highest tolerated dose.
5. Patient capable of understanding the study procedures and who gives their informed consent to participate

Exclusion criteria 16

1. Episodes of known clinically significant cardiac arrest or ventricular arrhythmias
2. Previous kidney or heart transplant
3. Severe hypomagnesemia (<1.4 mg/dl)
4. Active cancer, excluding non-melanocytic skin cancer, considered already cured
5. Treatment with anticancer drugs or immunotherapy
6. Pregnant or lactating women
7. History of drug or alcohol abuse
8. Continuous use of potassium supplements in the month prior to screening
9. Current use of calcium-containing or calcium-free phosphate chelators
10. Current use of polymer-based drugs such as cholestyramine, coveselam, or sodium polystyrene sulfonate
11. History of gastroparesis or intestinal obstruction, swallowing disorders, or major gastrointestinal surgery
12. History of stroke, myocardial infarction, decompensated heart failure, percutaneous coronary intervention or coronary bypass in the last 3 months
13. Patients with severe physical or mental disabilities that, in the opinion of the investigator, could interfere with the fulfillment of the study requirements
14. Presence of any condition that, in the opinion of the investigator, puts the patient at risk or could potentially impair the quality of the data
15. Drug or alcohol addiction that, in the investigator's opinion, could interfere with compliance with study requirements
16. Inability or unwillingness of the individual or legal guardian or representative to give written informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 6

1. Peripheral and central blood pressure.
2. Biomarcadores del metabolismo mineral (fosfato sérico, calcio y magnesio, FGF23, vitamina D y PTH)
3. 24-hour urinary excretion of phosphate, calcium, sodium, and potassium
4. Biomarkers of kidney damage: albumin/creatinine ratio, serum creatinine, eGFR
5. Endothelial function
6. Serum potassium concentration

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica De Cordoba

Sponsor organisation

Fundacion Para La Investigacion Biomedica De Cordoba

Address

Avenida Menendez Pidal S/n

City

Cordoba

Postcode

14004

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica De Cordoba

Contact name

José Carlos Garrido Gracia

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica De Cordoba

Contact name

José Carlos Garrido Gracia

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications