An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases

Study Purpose

The goal of this clinical study is to evaluate multiple dose levels of povetacicept (ALPN-303) in adults with immunoglobulin A (IgA) nephropathy, membranous nephropathy, or lupus-related kidney disease (lupus nephritis) to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key Inclusion Criteria Summary: 1. Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN) 2. Indication-specific criteria: 1. IgAN.

  • - UPCR ≥0.5 g/g.
2. pMN.
  • - Less than 50% reduction of proteinuria in the last 24 weeks while on angiotensin converting enzyme inhibitor (ACEis)/angiotensin II receptor blockers (ARBs) - UPCR ≥3.5 g/g.
  • - Positive anti-PLA2R1 antibodies or anti-THSD7A antibodies.
3. LN.
  • - UPCR ≥1 g/g, with additional criteria per protocol.
  • - Positive anti-dsDNA.
  • - Positive anti-nuclear antibody.
3. On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1. 4. Receiving stable dose(s) of standard-of-care medications and no prohibited concomitant medications per protocol. Key Exclusion Criteria Summary: 1. Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease. 2. eGFR <30 mL/min/1.73m2 or rapidly progressive glomerulonephritis. 3. Recent serious or ongoing infection; risk or history of serious infection

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Alpine Immune Sciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jiahua Li, M.D.
Principal Investigator Affiliation Alpine Immune Sciences, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Nephritis, Immunoglobulin A Nephropathy, Membranous Nephropathy
Arms & Interventions


Experimental: povetacicept 80mg

Experimental: povetacicept 240mg


Drug: - povetacicept

Administered by subcutaneous injection every 4 weeks

Drug: - povetacicept

Administered by subcutaneous injection every 4 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigational Site (501), Phoenix, Arizona




Investigational Site (501)

Phoenix, Arizona, 85302

Investigational Site (506), Valencia, California




Investigational Site (506)

Valencia, California, 91335

Investigational Site (512), Orlando, Florida




Investigational Site (512)

Orlando, Florida, 32806

Investigational Site (502), Lawrenceville, Georgia




Investigational Site (502)

Lawrenceville, Georgia, 30046

Investigational Site (511), Albany, New York




Investigational Site (511)

Albany, New York, 12209

Investigational Site (516), Houston, Texas




Investigational Site (516)

Houston, Texas, 77054