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)
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alpine Immune Sciences, Inc. Industry-sponsored |
| Locations | 253 sites (Huntsville, Alabama and 252 other locations) |
| Trial ID | NCT06564142 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
- Apogee Clinical Research, LLC — Huntsville, Alabama, United States (Recruiting)
- Arizona Kidney Disease and Hypertension Center - Thomas Office — Phoenix, Arizona, United States (Recruiting)
- Arizona Kidney Disease and Hypertension Center - Tuscon — Tucson, Arizona, United States (Recruiting)
- West Coast Kidney — Fremont, California, United States (Recruiting)
- CARE Institute - Carabello Kidney — Los Angeles, California, United States (Recruiting)
- Providence Medical Foundation - Orange — Orange, California, United States (Recruiting)
- Western Nephrology — Arvada, Colorado, United States (Recruiting)
- Colorado Kidney Care — Denver, Colorado, United States (Recruiting)
- Nephrology Associates Delaware Kidney — Newark, Delaware, United States (Recruiting)
- South Florida Nephrology Group PA, Research Div. — Coral Springs, Florida, United States (Recruiting)
- Dolphin Medical Research — Doral, Florida, United States (Recruiting)
- Nephrology Associates of Central Florida — Hollywood, Florida, United States (Recruiting)
- Tectum Medical Research, LLC — Hollywood, Florida, United States (Recruiting)
- South Florida Research Institute — Lauderdale Lakes, Florida, United States (Recruiting)
- Florida Kidney Physicians - Melbourne — Melbourne, Florida, United States (Recruiting)
- Med-Care Research — Miami, Florida, United States (Recruiting)
- Professional Research Center — Miami, Florida, United States (Recruiting)
- Nephrology Associates of South Miami — Miami, Florida, United States (Recruiting)
- On Health Research Center — Miami, Florida, United States (Recruiting)
- Combined Research Orlando Phase I-IV — Orlando, Florida, United States (Recruiting)
- BioResearch Partner — Pembroke Pines, Florida, United States (Recruiting)
- D&H Pompano Research Center — Pompano Beach, Florida, United States (Recruiting)
- Cordova Research Institute, LLC — Sweetwater, Florida, United States (Recruiting)
- SciMerge Clinical Research — Atlanta, Georgia, United States (Recruiting)
- Georgia Nephrology - Lawrenceville — Lawrenceville, Georgia, United States (Recruiting)
- Randomize Now - Midtown — Newnan, Georgia, United States (Recruiting)
- Care Institute - Chubbuck, ID — Chubbuck, Idaho, United States (Recruiting)
- Care Institute - Idaho Falls — Idaho Falls, Idaho, United States (Recruiting)
- CARE - Boise Kidney Institute — Meridian, Idaho, United States (Recruiting)
- Bioluminux Clinical Research — Naperville, Illinois, United States (Recruiting)
- Rockford Nephrology Associates — Rockford, Illinois, United States (Recruiting)
- Nephrology Associates of Northern Illinois and Indiana (NANI) — Indianapolis, Indiana, United States (Recruiting)
- Nephrology Physicians LLC — Mishawaka, Indiana, United States (Recruiting)
- Nephrology Associates of Kentuckiana — Louisville, Kentucky, United States (Recruiting)
- Renal Associates of Baton Rouge — Baton Rouge, Louisiana, United States (Recruiting)
- Velocity Clinical Research - Metairie — Metairie, Louisiana, United States (Recruiting)
- St. Clair Nephrology Research — Shelby, Michigan, United States (Recruiting)
- InterMed Consultants / DaVita Clinical Research, Edina — Edina, Minnesota, United States (Recruiting)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (Recruiting)
- Nephrology and Hypertension Associates, LTD — Tupelo, Mississippi, United States (Recruiting)
- Somnos Clinical Research — Lincoln, Nebraska, United States (Recruiting)
- DaVita Clinical Research Nevada - Las Vegas — Las Vegas, Nevada, United States (Recruiting)
- Bioluminux Clinical Research New Jersey — Hamilton, New Jersey, United States (Recruiting)
- New Jersey Kidney Care, LLC (FRENOVA) — Jersey City, New Jersey, United States (Recruiting)
- Renal Medicine Associates — Albuquerque, New Mexico, United States (Recruiting)
- New York Nephrology Vasculitis and Glomerular Center — Albany, New York, United States (Recruiting)
- Queens Hospital Center — Jamaica, New York, United States (Recruiting)
- Metrolina Nephrology Associates — Charlotte, North Carolina, United States (Recruiting)
- Nephrology Associates Inc — East Providence, Rhode Island, United States (Recruiting)
- Hypertension & Nephrology Inc. — Providence, Rhode Island, United States (Recruiting)
+203 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.