Prospective randomized study of tolerability and efficacy of combination therapy on chronic kidney disease

Prospective randomized study of tolerability and efficacy of combination therapy on chronic kidney disease - PROTECT-CKD Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001052

Enrollment

300

Registered

2008-02-26

Start date

2008-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic kidney diseases

Interventions

Loosartan and hydrochlorothiazide group Loosartan and enalapril group Loosartan and amlodipine group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) At 2 months after the therapy with 50 mg of losartan, systolic blood pressure is more than 130 mmHg and/or diastolic blood pressure is more than 80 mmHg. 2) Outpatients only 3) Written informed consent is required.

Exclusion criteria

Exclusion criteria: 1) Diastolic blood pressure is more than 120 mmHg. 2) HbA1cis more than 8.0%. 3) The occurrence of acute myocardial infarction, stroke, and the other vascular diseases within 6 months. 4) The patients who require calcium blocker for ischemic heart disease. 5) The patients with heart failure whose grade is more than NYHA III. 6) The patients with gout or hyperuricemia, which is more than 8.0 mg/dl at the start of the study. 7) Serum creatinine is more than 2.5 mg/dl. 8) AST or ALT is more than three-time of normal upper level 9) Bilateral renal artery stenosis 10) Endocrinological secondary hypertension 11) Autosomal dominant polycystic kidney disease, congenital anomaly of the kidney, unilateral agenesis of the kidney 12) Malignant hypertension 13) Possible or definite case of pregnancy, lactating women 14) The patients with the history of drug allergy to the study drugs.

Design outcomes

Primary

Measure	Time frame
Blood pressure changes at 4 months after the start of combination therapy	—

Secondary

Measure	Time frame
Changes in systolic blood pressure at 4 months after the start of combination therapy Rates of systolic blood pressure change and achievement of goal systolic blood pressure at 4 months after the start of combination therapy Rates of changes in urinary excretion of protein or albumin at 4 months after the start of combination therapy Rates and values of systolic blood pressure at 12 months after the start of combination therapy Rates of changes in urinary excretion of protein or albumin at 12 months after the start of combination therapy Changes in eGFR values at 12 months after the start of combination therapy Rates of achievement of goal blood pressure 12 months after the start of combination therapy Changes in HOMA-R Safety of the drugs throughout the study period	—

Measure

Time frame

Changes in systolic blood pressure at 4 months after the start of combination therapy Rates of systolic blood pressure change and achievement of goal systolic blood pressure at 4 months after the start of combination therapy Rates of changes in urinary excretion of protein or albumin at 4 months after the start of combination therapy Rates and values of systolic blood pressure at 12 months after the start of combination therapy Rates of changes in urinary excretion of protein or albumin at 12 months after the start of combination therapy Changes in eGFR values at 12 months after the start of combination therapy Rates of achievement of goal blood pressure 12 months after the start of combination therapy Changes in HOMA-R Safety of the drugs throughout the study period

—

Countries

Japan

Contacts

Public ContactMatsuhiko Hayashi

Keio University, School of Medicine Department of Internal Medicien

matuhiko@z3.keio.jp03-5363-3796

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026