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Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

PHASE3RECRUITING

The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.

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Study details:

The I CAN study will enroll approximately 450 eligible participants with IgAN who are high risk of disease progression. Participants will be on stable concomitant IgAN treatment(s) consistent with standard of care for patients with IgAN for at least 3 months prior to Screening, Participants will be randomized in a 1:1 allocation ratio to receive a weight-based IV infusion of either ravulizumab or placebo. An interim analysis may be conducted at Week 34 to evaluate change in proteinuria and the final analysis will be conducted at Week 106 to evaluate eGFR.

In addition, approximately 20 participants with eGFR 20-29 mL/min/1. 73m2 will be enrolled in an Exploratory Cohort and will receive open label weight-based IV infusion of ravulizumab. After Week 106, all participants have the option to enter a post-study access period and receive open-label ravulizumab.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period.

UPCR ≥ 0.75 g/g or UP ≥1 g/day from the mean of two 24-hour urine collections during Screening.

Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.

Exploratory Cohort: eGFR 20-29 mL/min/1.73 m2 at Screening. A kidney biopsy is required within 6 months prior to Screening or during the Screening Period.

Presence of hematuria as defined by a positive result on urine dipstick for blood or ≥ 5 red blood cells (RBCs)/high power field microscopy on urine sediment during or within 3 months of Screening.

Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.

Participants who are on an SGLT2I, ERA, or MRA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change through Week 106.

Exclusion criteria

Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.

Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease).

Concomitant clinically significant renal disease other than IgAN.

Prior use of immunosuppressive treatment for IgAN within 6 months of screening.

Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.

Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring ongoing systemic immunosuppressive therapy at Screening.

History of kidney transplant or planned kidney transplant during the Treatment Period.

Splenectomy or functional asplenia.

History of Neisseria meningitidis infection.

Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-03-29

Primary completion: 2026-02-23

Study completion finish: 2029-10-25

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06291376

Intervention or treatment

DRUG: Ravulizumab

DRUG: Placebo

Conditions

• Immunoglobulin A Nephropathy
• IgAN

Image related to Immunoglobulin A Nephropathy

Condition: Immunoglobulin A Nephropathy, IgAN
DRUG: Ravulizumab and other drugs
Camperdown, Not Specified, Australia and more
Sponsor: Alexion Pharmaceuticals, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Research Site

Research sites nearby

Select from list below to view details:

Research Site
Camperdown, Not Specified, Australia
Research Site
Canberra, Not Specified, Australia
Research Site
Clayton, Not Specified, Australia
Research Site
Concord, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ravulizumab IV q8w Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w). Participants in the exploratory group will receive open-label weight based loading dose on Day 1 followed by open label weight based maintenance dose on Day 15 and q8weeks after.	DRUG: Ravulizumab Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
PLACEBO_COMPARATOR: Placebo IV q8w Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.	DRUG: Placebo Participants will receive placebo via weight-based IV infusion.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34	Evaluated at interim analysis only	Baseline, Week 34
Glomerular Filtration Rate (eGFR) Over 106 Weeks	Evaluated at final analysis only	Up to Week 106

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106	Evaluated at interim and final analysis	Baseline, Weeks 10, 26, 34, 50, and 106
Change From Baseline in eGFR at Weeks 34, 50, and 106	Evaluated at interim and final analysis	Baseline, Weeks 34, 50, and 106
Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106	Evaluated at interim and final analysis	Baseline, Weeks 10, 26, 34,50, and 106
Reduction in 24-hour UPCR ≥ 50% From Baseline to Weeks 10, 26, 34, 50, and 106	Evaluated at interim and final analysis	Baseline, Weeks 10, 26, 34, 50, and 106
Number of Participants With Partial Remission at Weeks 34, 50, and 106	Evaluated at interim and final analysis	Weeks 34, 50, and 106
Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106	Evaluated at interim and final analysis	Baseline, Weeks 34, 50, and 106
Number of Participants With Composite Kidney Failure Endpoint	Composite kidney failure endpoint is defined as reaching at least 1 of the following: Sustained ≥ 30% decline in eGFR relative to baseline; or Sustained eGFR \< 15 milliliter (mL)/minute (min)/1.73 square meter (m\^2); or Maintenance dialysis; or Receipt of kidney transplant; or Death from kidney failure. Evaluated at the final analysis only	Baseline up to Week 106
Reduction in 24-hour UPCR ≥ 50% From Baseline at both Weeks 34 and 106	Evaluated at the final analysis only	Baseline, Weeks 34 and 106
Number of Participants With Kidney Hierarchical Composite Endpoint	The kidney hierarchical composite endpoint is defined as the most severe outcome of a participant according to the following severity of outcomes: death from kidney failure, kidney transplant, maintenance dialysis, sustained eGFR \< 15 mL/min/1.73 m\^2, sustained eGFR decline from baseline ≥ 30%, or eGFR slope. Evaluated at the final analysis only	Baseline up to Week 106

Frequently Asked Questions

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References

Clinical Trials Gov: Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)