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New hope for kidney disease: early combo therapy may slow IgA nephropathy

NCT ID NCT03188887

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

62 people

The number who actually took part.

Started

Feb 2018

Finished

Jan 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Hôpital Necker Enfants-malades

    Paris, Paris, 75015, France

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Other studies related to the condition(s) this trial covers.