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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03841448
• Date of registration: 13/02/2019
• Prospective Registration: Yes
• Primary sponsor: Alnylam Pharmaceuticals
• Public title: A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
• Scientific title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy
• Date of first enrolment: September 30, 2019
• Target sample size: 31
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03841448
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada, France, Malaysia, Philippines, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Alnylam Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy (IgAN)

Berger Disease

Glomerulonephritis, IgA

Intervention(s)

Drug: Cemdisiran

Drug: Placebo

Primary Outcome(s)

Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32 [Time Frame: Baseline to Week 32]

Secondary Outcome(s)

Number of Participants With Change From Baseline in Hematuria at Week 32 [Time Frame: Baseline to Week 32]

Percentage of Participants With Partial Clinical Remission at Week 32 [Time Frame: Week 32]

Change From Baseline in UPCR as Measured in a Spot Urine at Week 32 [Time Frame: Baseline to Week 32]

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline up to 240 weeks]

Percent Change From Baseline in 24-hour Proteinuria at Week 32 [Time Frame: Baseline to Week 32]

Percentage of Participants With >50% Reduction in 24-hour Proteinuria at Week 32 [Time Frame: Week 32]

Secondary ID(s)

2018-002716-27

ALN-CC5-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/12/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03841448