Evaluating a new treatment for IgA nephropathy in adults

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)

Phase 3 Interventional Alpine Immune Sciences, Inc. · NCT06564142

This study is testing a new treatment called povetacicept to see if it can help adults with IgA nephropathy by improving their kidney function and reducing protein in their urine.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment480 (estimated)
Ages18 Years and up
SexAll
SponsorAlpine Immune Sciences, Inc. Industry-sponsored
Locations253 sites (Huntsville, Alabama and 252 other locations)
Trial IDNCT06564142 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of povetacicept in adults diagnosed with Immunoglobulin A Nephropathy (IgAN) compared to a placebo. Participants will be monitored for changes in proteinuria levels and renal function over the course of the study. Eligible individuals must have confirmed IgAN and meet specific criteria regarding proteinuria and kidney function. The study will involve multiple locations in Arizona and will follow a rigorous protocol to ensure participant safety and data integrity.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with IgAN who have specific levels of proteinuria and kidney function.

Not a fit: Patients who have received recent immunosuppressive treatments or have rapidly progressive glomerulonephritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce proteinuria and help preserve kidney function in patients with IgAN.

How similar studies have performed: Other studies have explored treatments for IgAN, but the specific approach of using povetacicept is novel and has not been widely tested.

Eligibility criteria

Show full inclusion / exclusion criteria
Key Inclusion Criteria:

* Diagnosed IgAN, with biopsy confirmation
* 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
* Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification

Key Exclusion Criteria:

* Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
* Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening

Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Huntsville, Alabama and 252 other locations

+203 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Immunoglobulin A NephropathyIgANBerger's diseaseglomerulonephritisIgA nephropathyALPN-303BAFFBLyS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.