A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)

Phase 2TerminatedNCT03841448

Alnylam Pharmaceuticals31 enrolled

Overview

The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete \>1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB). These participants are at high risk for progression of kidney disease, which can result in end-stage renal failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

IgA Nephropathy (IgAN)Berger Disease Glomerulonephritis, IgA

Interventions

PlaceboDRUG

Normal saline (0.9% NaCl) matching volume of cemdisiran doses were administered SC.

CemdisiranDRUG

Cemdisiran was administered by SC injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with primary IgAN * Currently being treated for IgAN with stable, optimal therapy, including an ACE inhibitor or ARB. * Has urine protein greater than or equal to 1 gram/24-hour * Has hematuria (blood cells present in urine) Exclusion Criteria: * Has renal disease other than IgAN * Has a diagnosis of rapidly progressive glomerulonephritis * Has a diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis) * Has poor kidney function with estimated glomerular filtration rate (eGFR) \<30 milliliters per minute per 1.73 meters square (mL/min/1.73 m\^2) * Has known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection or hepatitis B virus (HBV) infection * Has on-going high blood pressure * Treated with systemic corticosteroids for more than 7 days, or other immunosuppressant agents in the past 6 months * Received an organ transplant

Locations (17)

Clinical Trial Site

Vancouver, British Columbia, Canada

Clinical Trial Site

Brampton, Ontario, Canada

Clinical Trial Site

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32

UPCR is a way of assessing the amount of protein in the urine. The primary analysis for UPCR was performed using Mixed-Effect Model Repeated Measures (MMRM) approach. Geometric mean (GM)ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h UPCR. Standard error of the mean (SEM) was calculated as exponential (mean of change in log-transformed data) \* (standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% confidence interval (CIs) were calculated by exponentially back-transforming the model-based least square (LS) mean and the corresponding 90% CI.

Time frame: Baseline to Week 32

Secondary Outcomes

Percent Change From Baseline in 24-hour Proteinuria at Week 32

Proteinuria is high levels of protein in the urine. 24-hour proteinuria assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Analysis was performed using the MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h urine protein (UP). SEM was calculated as exp (mean of change in log-transformed data) \*(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.

Time frame: Baseline to Week 32

Percentage of Participants With Partial Clinical Remission at Week 32

Partial clinical remission was defined as having UP \<1.0 g/24-hours.

Time frame: Week 32

Percentage of Participants With >50% Reduction in 24-hour Proteinuria at Week 32

Time frame: Week 32

Change From Baseline in UPCR as Measured in a Spot Urine at Week 32

UPCR was calculated by dividing the level of protein in a spot urine test by the creatinine level. Analysis was performed using MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed spot UPCR. SEM was calculated as exp (mean of change in log-transformed data) \*(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.