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

Sponsor
Alnylam Pharmaceuticals
Study ID
NCT03841448
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Normal saline (0.9% NaCl) matching volume of cemdisiran doses were administered SC.
  • Cemdisiran — DRUG
    Cemdisiran was administered by SC injection.

Study Details

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.

Key Dates

Start date
Sep 30, 2019
Status verified
Jun 2024
Primary completion
Mar 17, 2022
Completion
Jun 27, 2023

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Double-Blind Treatment (DBT) Period: Cemdisiran
    Participants received cemdisiran, 600 milligrams (mg), subcutaneous (SC) injection, once every 4 weeks (Q4W) in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
  • Placebo Comparator: DBT Period: Placebo
    Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
  • Experimental: DBT Period: Cemdisiran to Open-Label Extension (OLE) Period: Cemdisiran
    Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.
  • Placebo Comparator: DBT Period: Placebo to OLE Period: Cemdisiran
    Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.

Primary Outcome Measure

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

Related Studies