Clinical trial NCT03841448: A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: IgA Nephropathy (IgAN)
Berger Disease
Glomerulonephritis, IgA
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32
timeFrame: Baseline to Week 32
Secondary outcomes:
measure: Percent Change From Baseline in 24-hour Proteinuria at Week 32
timeFrame: Baseline to Week 32
measure: Percentage of Participants With Partial Clinical Remission at Week 32
timeFrame: Week 32
measure: Percentage of Participants With >50% Reduction in 24-hour Proteinuria at Week 32
timeFrame: Week 32
measure: Change From Baseline in UPCR as Measured in a Spot Urine at Week 32
timeFrame: Baseline to Week 32
measure: Number of Participants With Change From Baseline in Hematuria at Week 32
timeFrame: Baseline to Week 32
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 126 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Clinical Trial Site
state: British Columbia
city: Brampton
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Grenoble
country: France
facility: Clinical Trial Site
city: La Tronche
country: France
facility: Clinical Trial Site
city: Mulhouse
country: France
facility: Clinical Trial Site
city: Kuala Lumpur
country: Malaysia
facility: Clinical Trial Site
city: Kuantan
country: Malaysia
facility: Clinical Trial Site
city: Serdang
country: Malaysia
facility: Clinical Trial Site
city: Quezon City
country: Philippines
facility: Clinical Trial Site
city: Singapore
country: Singapore
facility: Clinical Trial Site
city: Córdoba
country: Spain
facility: Clinical Trial Site
city: Girona
country: Spain
facility: Clinical Trial Site
city: Huddinge
country: Sweden
facility: Clinical Trial Site
city: Uppsala
country: Sweden
facility: Clinical Trial Site
city: Taichung
country: Taiwan
facility: Clinical Trial Site
city: Leicester
country: United Kingdom
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References: