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A single center, positive control and prospective clinical study on the renal protective effect of tolvaptan versus loop diuretic in the treatment of patients with moderate and severe edema of CKD

A single center, positive control and prospective clinical study on the renal protective effect of tolvaptan versus loop diuretic in the treatment of patients with moderate and severe edema of CKD

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066643
Enrollment
Unknown
Registered
2022-12-12
Start date
2022-12-15
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Patients with moderate and severe edema of CKD

Interventions

Tolvaptan alone treatment group:Tolvaptan
Tolvaptan combined with low-dose loop diuretics treatment group:Tolvaptan combined with loop diuretics
loop diuretic alone treatment group:loop diuretic

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age = 18 years old and = 85 years old, regardless of gender; 2) Patients who meet the diagnostic criteria of chronic kidney disease and have moderate or above edema; 3) Voluntarily participate in this experiment, understand and sign the informed consent form; 4) The subjects were able to complete the study in accordance with the provisions of the study.

Exclusion criteria

Exclusion criteria: 1) Severe liver function damage, child Pugh grade C (10 points or higher); 2) Low blood volume status assessed clinically; 3) Hypernatremia; 4) Recent use of nephrotoxic drugs; 5) Unable to cope with thirst, or unable to perceive thirsty objects; 6) Any major history of drug allergy; 7) Any situation that the researcher believes is not suitable for participating in the study; 8) The patients who participated in the study were employees of the center or relatives of researchers; 9) Participate in clinical research of other drugs or devices; 10) Any disease or condition that reduces the life expectancy of the patient. 11)Dialysis patients, patients with kidney diseases and immune diseases, patients with hormone and immunosuppressive drugs

Design outcomes

Primary

MeasureTime frame
estimated glomerular filtration rate;

Secondary

MeasureTime frame
Serum creatinine;Cystatin C;serum total protein;albumin;brain natriuretic peptide;NT-proBNP;Blood potassium and sodium;blood clotting;24-hour cumulative urine volume;24-hour urinary protein quantitation;weight;Edema score;

Countries

China

Contacts

Public ContactLi Zhou

China-Japan Friendship Hospital

zhoulizryh@126.com15801421881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026