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Efficacy and safety of dapagliflozin in patients with primary nephropathy treated with glucocorticoids: A pilot study

Efficacy and safety of dapagliflozin in patients with primary nephropathy treated with glucocorticoids: A pilot study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058174
Enrollment
Unknown
Registered
2022-03-31
Start date
2022-04-10
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Nephropathy

Interventions

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with primary kidney disease confirmed by renal biopsy; 2. The subject shall sign the informed consent form in person before the start of any procedures related to the study, fully understand the purpose or significance of the study, and be willing to abide by the study protocol; 3. Age >=18 and =0.5mg/kg/d at least 4 weeks before enrollment, combined with/without immunosuppressive therapy; 5. Urinary protein excretion >500 mg/24 h and =30mL/min/m2 (CKD-EPI formula).

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus (T1D); 2. Peripheral Vascular Disease; 3. Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease; 4. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor; 5. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment; 6. Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: (1) History of active inflammatory bowel disease within the last six months; (2) Major gastrointestinal surgery, such as gastrectomy, gastroenterostomy or enterectomy; (3) Gastrointestinal ulcer and/or gastrointestinal or rectal bleeding within the last 24 weeks; (4) Pancreatic injury or pancreatitis in the past six months; (5) The presence of liver injury determined by clinicians (aspartate aminotransferase or alanine aminotransferase before admission exceeding the Upper limit of 3 times normal value; Or total bilirubin at the time of inclusion exceeding Upper limit of 2 normal values); 7. There are fertility requirements in recent 1-year pregnancy or breastfeeding; 8. Participation in any other clinical investigation within 1 year; 9. Any psychological or psychological disease or condition that, as determined by the study physician, may increase the risk of the study affecting the subjects' adherence to the protocol or affecting the subjects' completion of the study includes but is not limited to: (1) Patients at risk for dehydration or hypovolemia (e.g., hypotensive postural dizziness, orthostatic hypotensive syncope and dehydration); (2) Patients with acute kidney injury in the last 1 month; (3) Severe mental illness or cognitive impairment (e.g. dementia); (4) Any other relevant acute or chronic neuropsychiatric illness (e.g., encephalopathy, coma and delirium) within 3 months prior to screening; (5) Patients with malignant tumors (including cured and non-recurrent malignant tumors).

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin;Fasting plasma glucose;Total cholesterol;Triglyceride;Low density lipoprotein;HDL-Cholesterol;

Secondary

MeasureTime frame
Creatinine;Blood urea nitrogen (BUN);Uric Acid;Estimated glomerular filtration rate;Systolic pressure;Diastolic pressure;Body Mass Index;Serum potassium;Serum sodium;Serum chlorine;Serum calcium;Serum phosphate;Carbon dioxide combining power;Hemoglobin;Glutamic-pyruvic transaminase;Glutamic oxalacetic transaminase;Cardiovascular death;Myocardial infarction;Cardiac failure;24-hour urinary protein quantity;

Countries

China

Contacts

Public ContactZhiguo Mao

Shanghai Changzheng Hospital

maozhiguo93@126.com+86 13601941319

Outcome results

None listed

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