IgA nephropathy
Conditions
Interventions
Test group:Combined with fecal microbiota transplantation (capsules) on the basis of basic treatment. The chief physician of our center formulates the basic treatment plan after a comprehensive assess
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 70 years old; 2. Pathological diagnosis of primary IgA nephropathy; 3. Estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73 m²; 4. Treated with the maximum tolerated dose of angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB) and/or sodium-glucose cotransporter 2 inhibitor (SGLT2i), and after 3 - 6 months of treatment with hormones and/or immunosuppressants, or after a full course of biological agents, the 24-hour urine protein quantification > 1.0 g; 5. After treatment with hormones and/or immunosuppressants and/or biological agents, recurrence occurs, and the 24-hour urine protein quantification is still > 1.0 g; 6. During the application of hormones and/or immunosuppressants and/or biological agents, intolerable toxic and side effects occur, making it unsuitable to receive further treatment with hormones, immunosuppressants or biological agents, and the 24-hour urine protein quantification > 1.0 g; 7. Agree to participate in this project and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe cardiovascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors and other diseases with an expected survival time of less than 3 months, combined with other autoimmune diseases, diabetes; 2. Active gastrointestinal bleeding; 3. Acute and chronic gastroenteritis; 4. Having received or currently receiving fecal microbiota transplantation treatment; 5. Infected with HIV; 6. Mental illness or intellectual disability; 7. Women with a pregnancy plan within 18 months or women who are breastfeeding; 8. History of alcohol/drug abuse; 9. Other situations considered by the researcher as inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in 24-hour urine protein quantification during the 6-month treatment period. ;The change in serum creatinine concentration during the treatment period and the follow-up period; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in 24-hour urine protein quantification during the follow-up period;The change slope of eGFR during the treatment period and the follow-up period;The change in serum albumin concentration during the treatment period and the follow-up period;The change in urine protein to creatinine ratio (UPCR) and urine albumin to creatinine ratio (UACR) during the treatment period and the follow-up period;The change in the count of urinary red blood cells during the treatment period and the follow-up period;The change of Gd-IgA1, B-cell activating factor (BAFF), a proliferation-inducing ligand (APRIL) compared with the baseline during the treatment period and the follow-up period;The change of gut microbiota during the treatment period and the follow-up period; | — |
Countries
China
Contacts
Public ContactShiren Sun
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed