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THINK - intensification of blood pressure lowering Therapeutics based on diuretics versus usual management for uncontrolled Hypertension IN patients with moderate to severe chronic Kidney disease: an open label, cluster randomized controlled, phase 3 trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501494-39-00
Acronym
DR210320
Enrollment
720
Registered
2023-01-23
Start date
2023-03-28
Completion date
Unknown
Last updated
2025-04-11

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

Conditions

Uncontrolled Hypertension IN patients with moderate to severe chronic Kidney disease

Brief summary

Time to event outcome, considering the following composite endpoint: end stage kidney disease (need for kidney replacement therapy or renal transplantation), eGFR decline ≥40% (CKD-EPI formula), cardiovascular events (myocardial infarction, heart failure hospitalization, stroke), all cause mortality

Detailed description

Time to end-stage kidney disease, Time to eGFR decrease ≥40%, Time to the first cardiovascular event (myocardial infarction, heart failure hospitalization, stroke), All cause mortality, Change from baseline systolic and diastolic blood pressure at months 3 and 6 then every 6 months (home blood pressure monitoring and office blood pressure measurement), Proportion of patients with controlled blood pressure at 2 years (PA< 135 and/or 85mmHg with home blood pressure monitoring), Change from baseline in glomerular filtration rate estimated by CKD-EPI formula at months 3 and 6 then every 6 months, Change from baseline in proteinuria (g/d) or proteinuria /creatininuria (g/g) at months 3 and 6 then every 6 months, Proportion of patients who used at least one diuretic, Change from baseline in quality of life assessed by PROMIS-29 survey each year, Safety: volume depletion, dyskalemia, hyponatremia, acute kidney injury, gout, orthostatic hypotension symptomatic/asymptomatic or complicated by falls

Interventions

DRUGAMILORIDE HYDROCHLORIDE
DRUGHYDROCHLOROTHIAZIDE
DRUGFUROSEMIDE

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to event outcome, considering the following composite endpoint: end stage kidney disease (need for kidney replacement therapy or renal transplantation), eGFR decline ≥40% (CKD-EPI formula), cardiovascular events (myocardial infarction, heart failure hospitalization, stroke), all cause mortality

Secondary

MeasureTime frame
Time to end-stage kidney disease, Time to eGFR decrease ≥40%, Time to the first cardiovascular event (myocardial infarction, heart failure hospitalization, stroke), All cause mortality, Change from baseline systolic and diastolic blood pressure at months 3 and 6 then every 6 months (home blood pressure monitoring and office blood pressure measurement), Proportion of patients with controlled blood pressure at 2 years (PA< 135 and/or 85mmHg with home blood pressure monitoring), Change from baseline in glomerular filtration rate estimated by CKD-EPI formula at months 3 and 6 then every 6 months, Change from baseline in proteinuria (g/d) or proteinuria /creatininuria (g/g) at months 3 and 6 then every 6 months, Proportion of patients who used at least one diuretic, Change from baseline in quality of life assessed by PROMIS-29 survey each year, Safety: volume depletion, dyskalemia, hyponatremia, acute kidney injury, gout, orthostatic hypotension symptomatic/asymptomatic or complicated by f

Countries

France

Outcome results

None listed

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