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PROMISE: Potassium correction for RAAS Optimization in Chronic Kidney Disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505626-34-01
Enrollment
44
Registered
2024-01-26
Start date
2024-05-16
Completion date
Unknown
Last updated
2025-12-12

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

Conditions

Chronic kidney disease

Brief summary

The main trial endpoint is 24-hour urinary albumin excretion, adjusted for creatinine (albumin-creatinine ratio, ACR), at the end of each study period.

Detailed description

The main secondary endpoint is systolic and diastolic blood pressure, assessed by a 24-hour ambulatory blood pressure measurement at the end of each study period. Further secondary endpoints are plasma potassium levels, kidney function, as reflected by the estimated glomerular filtration rate (eGFR) using the combined cystatin C-creatinine-based CKD-EPI formula, the achieved irbesartan dose and the number of (sever) adverse events at the end of each study period.

Interventions

DRUGIRBESARTAN
DRUGPATIROMER CALCIUM
DRUGmicrocrystalline cellulose and xanthan gum

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The main trial endpoint is 24-hour urinary albumin excretion, adjusted for creatinine (albumin-creatinine ratio, ACR), at the end of each study period.

Secondary

MeasureTime frame
The main secondary endpoint is systolic and diastolic blood pressure, assessed by a 24-hour ambulatory blood pressure measurement at the end of each study period. Further secondary endpoints are plasma potassium levels, kidney function, as reflected by the estimated glomerular filtration rate (eGFR) using the combined cystatin C-creatinine-based CKD-EPI formula, the achieved irbesartan dose and the number of (sever) adverse events at the end of each study period.

Countries

Netherlands

Outcome results

None listed

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