New hope for kidney disease: early combo therapy may slow IgA nephropathy
NCT ID NCT03188887
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding early steroids or SGLT2 inhibitors to standard blood pressure medication can better protect kidney function in people with IgA nephropathy who have severe kidney damage. 62 adults with active disease were randomly assigned to receive either the combination therapy or standard care alone. The goal was to see if the extra treatment could prevent worsening kidney function over two years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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62 people
The number who actually took part.
- Started
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Feb 2018
- Finished
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Jan 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \>= 18 years 2. Patient with IgAN 3. Renal biopsy \< 45 days before inclusion visit 4. PCR ratio \>0.75 g/g (within 30 days before or after the renal biopsy) 5. Renal biopsy with at least 8 glomeruli, disclosing at least 2 criteria among: * mesangial proliferation (according to Oxford criteria) * endocapillary proliferation (according to Oxford criteria) * tubulointerstitial fibrosis (according to Oxford criteria) \>25% of the biopsy * segmental glomerulosclerosis (according to Oxford criteria) * at least 1 cellular/fibrocellular crescents (C1 according to Oxford criteria) 6. Patient with Social Security Insurance or CMU 7. Patient having signed an informed consent Exclusion Criteria: 1. \>30% increase of serum creatinine after starting nephroprotection therapy (≥ 15 days and ≤ 6 weeks) only for patient under nephroprotection \<45 days of the inclusion visit 2. \>50% cellular/fibrocellular crescents, or \>50% tubulointerstitial fibrosis or \>50% globally sclerotic glomeruli 3. Nephrotic syndrome with minimal change disease and IgA deposits 4. eGFR \<20 ml/min/1,73m2 (CKD-EPI formula) within 30 days before or after the renal biopsy 5. Uncontrolled blood pressure (Systolic blood pressure \>180 mmHg or diastolic blood pressure \> 110 mmHg) 6. Previous corticosteroids treatment (\>20 mg/d during more than 15 days, within the last 3 months before the renal biopsy) 7. Pregnancy or breast feeding or women without sufficient contraception 8. Secondary known forms of IgAN 9. Henoch-Schoenlein purpura 10. Additional other chronic renal disease 11. Contraindication for immunosuppressive therapy, including active intestinal bleeding, active gastric or duodenal ulcer; active infection; any malignancy in a last years before the inclusion; severe psychiatric disease; living vaccines; anti-inflammatory dosages of acetylsalicylic acid 12. Contraindication for RAS orSGLT2i blockade therapy 13. Known allergy or intolerance to corticoids or lactose 14. Organ transplant patient
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Necker Enfants-malades
Paris, Paris, 75015, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new injection slow kidney disease in children?