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NCT Number: NCT06564142

Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)

The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Immunoglobulin A Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Grampians Health Ballarat, Ballarat, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povetacicept

Drug

Subcutaneous injection administration.

Other names: ALPN-303

Placebo (matched to Povetacicept)

Drug

Placebo matched to Povetacicept subcutaneous injection administration.

Primary outcomes

  1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36

    Time frame: From Baseline at Week 36

  2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104

    Time frame: From Baseline Through Week 104

Secondary outcomes

  1. Change from Baseline in Serum Gd-IgA1 at Week 36

    Time frame: From Baseline at Week 36

  2. Proportion of Participants to Achieve Hematuria Resolution at Week 36 (Among Participants With Hematuria at Baseline)

    Time frame: From Baseline at Week 36

  3. Change From Baseline in eGFR at Week 104

    Time frame: From Baseline at Week 104

  4. Time to Kidney Disease Progression Through Week 104

    Time frame: From Baseline Through Week 104

    Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death

Sponsors and collaborators

Lead sponsor

Alpine Immune Sciences Inc, A Subsidiary of Vertex

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 21, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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