Patiromer Trial in CKD Stage IIIB to V

PHASE3TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

August 2, 2023

Primary Completion Date

November 7, 2024

Study Completion Date

November 7, 2024

Conditions
Hyperkalemia
Interventions
DRUG

Veltassa Oral Powder Product

"The recommended starting dose is 8.4 g of patiromer, once daily (equivalent to one packet of the active ingredient, once daily). The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued.~Patients are expected to be included during an 18-month recruitment period. The last randomized patient will be maintained on active follow-up for 6 months. All other randomized patients will be maintained on active follow-up until the last randomized patient will have completed the planned 6-month follow-up period. Thus, the follow-up period will be expected to range from a minimum of 6 months for the last randomized patient to a maximum of 24 months for the first randomized patient"

OTHER

Placebo

"The recommended starting dose is 8.4 g of patiromer, once daily (equivalent to one packet of the active ingredient, once daily). The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued.~Patients are expected to be included during an 18-month recruitment period. The last randomized patient will be maintained on active follow-up for 6 months. All other randomized patients will be maintained on active follow-up until the last randomized patient will have completed the planned 6-month follow-up period. Thus, the follow-up period will be expected to range from a minimum of 6 months for the last randomized patient to a maximum of 24 months for the first randomized patient"

Trial Locations (1)

24020

"Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò", Ranica

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Vifor Pharma

INDUSTRY

lead

Mario Negri Institute for Pharmacological Research

OTHER