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A multicenter, prospective, randomized controlled clinical study of rosalastat in the treatment of acute renal injury secondary to primary nephrotic syndrome

A multicenter, prospective, randomized controlled clinical study of rosalastat in the treatment of acute renal injury secondary to primary nephrotic syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068463
Enrollment
Unknown
Registered
2023-02-20
Start date
2023-02-21
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Acute renal injury

Interventions

Experimental group:Rosalastat + Remove risk factors and incentives + Support treatment
control group:Remove risk factors and incentives + Support treatment

Sponsors

Central Hospital Affiliated to Chongqing University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Voluntary participation and written informed consent; 2. Gender is not limited, age is 16-70 years old; 3. The subject shall meet the following conditions to be diagnosed as PNS with AKI: (1) meet the clinical diagnostic criteria of primary nephrotic syndrome: 1) massive proteinuria (proteinuria >= 3.5g/d), hypoalbuminemia (plasma albumin less than 30g / L), or accompanied by (high) edema and hyperlipidemia; 2) provide renal pathology report] during the hospitalization, the patient shall also meet (2) the diagnostic criteria of AKI (KDIGO): 1) the rise of SCR within 48 hours exceeds 26.5 µ mol/L(0.3 mg/dl); 2) Confirm or speculate that the increase of SCR within 7 days exceeds 50% of the baseline; 3) Urine volume reduction < 0.5 ml / (kg · h), lasting for 6 hours or more (when urine volume change is used as the diagnostic standard alone, it is necessary to exclude urinary tract obstruction or other factors that may lead to urine volume reduction). 4) Be able to follow the study or follow-up procedures.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria shall not be included in the study: 1. Excluding nephrotic syndrome induced by secondary factors: such as genetic diseases, infectious diseases, such as secondary nephrotic syndrome caused by hepatitis B virus infection and allergic purpura, connective tissue diseases, such as systemic lupus erythematosus nephropathy, secondary nephrotic syndrome caused by related drugs, metabolic diseases, such as diabetes, abnormal proteinemia, such as amyloidosis, multiple myeloma, and new biological related nephrotic syndrome. 2. Women who have recent family planning, pregnancy or breastfeeding; 3. Unable to understand the potential risks and benefits of the study, and unable to follow up and evaluate as required; 4. No capacity for civil conduct; 5. History of drug or alcohol abuse; 6. There are any more complicated medical problems that may interfere with the research behavior or lead to increased risk, such as malignant tumor, liver disease (transaminase >= 2 times the normal upper limit), AIDS, viral hepatitis, etc.; 7. Those who are allergic to drugs and are not suitable to use "roxarstat".

Design outcomes

Primary

MeasureTime frame
Blood creatinine;estimated glomerular filtration rate;

Secondary

MeasureTime frame
24-hour urine protein quantification;Blood albumin;TC;TG;LDL-C;HDL-C;

Countries

China

Contacts

Public ContactChen Xingqing

Central Hospital Affiliated to Chongqing University

chenxingqing2022@163.com+86 23 6369 2481

Outcome results

None listed

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