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The Effect of Sirolimus in Treating IgA Nephropathy: a Single Center Prospective Exploratory Study

The Effect of Sirolimus in Treating IgA Nephropathy: a Single Center Prospective Exploratory Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066031
Enrollment
Unknown
Registered
2022-11-22
Start date
2022-11-22
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

IgA Nephropathy

Interventions

experimental group:Sirolimus: initial dose 1mg/d, target trough concentration 5-8µg/L,and supportive treatment

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: When patients meet conditions A-C, they enter a screening period during which they follow the usual treatment with an intensive support approach. If conditions A-E are met, you can be added to the group: A) Age: 18-69 years old; B) Primary IgA nephropathy confirmed by renal perforation pathology within the past year; C) Patients or family members can understand the study protocol and are willing to participate in the study, providing written informed consent; D) eGFR=30ml/min/1.73m2 (calculated using the ckd-epi formula) after at least 4 weeks of intensive supportive therapy; E) 24-hour urinary total protein 0.75 -- 3.0g after at least 4 weeks of intensive supportive therapy.

Exclusion criteria

Exclusion criteria: We exclude patients who have any of the following conditions:: A)Secondary IgA nephropathy, such as systemic lupus erythematosus, cirrhosis, IgA vasculitis, or other chronic kidney disease; B) Use of immunosuppressive therapy, including hormones or immunosuppressive agents, in the past 1 year; C) Other indications of the use of hormones or immunosuppressants, including IgA nephropathy with minimal lesions and the presence of crescents in > 50% of glomeruli in renal perforation pathology D) Combined with other circumstances affecting the use of rapamycin: (1) Active or occult infection, including HBV, CMV infection or latent or active tuberculosis; (2) have been diagnosed with malignant tumors within the last 5 years; (3) Current pregnancy or lactation (4) A woman of reproductive age has a family planning while taking medication E) Unqualified hypertension control (systolic blood pressure > 160mmHg or diastolic blood pressure > 110mmHg) F) The clinician judged that the patient was unable to comply with the study protocol G) Participate in other clinical trials at the same time H) Withdrawal criteria: After enrollment, patients requested to withdraw from the study due to various considerations.

Design outcomes

Primary

MeasureTime frame
Serum Creatinine;24 hour urine protein;Serum albumin;blood lipid;

Countries

China

Contacts

Public ContactXuemei Li

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

kellyz_0_67@163.com010-69154056

Outcome results

None listed

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