Adults 18 to 65, any sex, with IgA Nephropathy (IgAN) or Berger Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32Primary· Baseline to 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 squ
Group
Value
95% CI
DBT Period: Placebo
1.095
± 0.258
DBT Period: Cemdisiran
0.686
± 0.098
Percent Change From Baseline in 24-hour Proteinuria at Week 32Secondary· Baseline to 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 correspondi
Group
Value
95% CI
DBT Period: Placebo
1.051
± 0.266
DBT Period: Cemdisiran
0.671
± 0.104
Percentage of Participants With Partial Clinical Remission at Week 32Secondary· Week 32
Partial clinical remission was defined as having UP \<1.0 g/24-hours.
Group
Value
95% CI
DBT Period: Placebo
0
DBT Period: Cemdisiran
22.7
Percentage of Participants With >50% Reduction in 24-hour Proteinuria at Week 32Secondary· Week 32
Group
Value
95% CI
DBT Period: Placebo
0
DBT Period: Cemdisiran
22.7
Change From Baseline in UPCR as Measured in a Spot Urine at Week 32Secondary· Baseline to 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.
Group
Value
95% CI
DBT Period: Placebo
1.344
± 0.139
DBT Period: Cemdisiran
0.729
± 0.109
Number of Participants With Change From Baseline in Hematuria at Week 32Secondary· Baseline to Week 32
Hematuria is the presence of blood in the urine. Hematuria from spot urine collections was evaluated to assess the effect of cemdisiran on disease course in participants. The degree of hematuria was assessed by microscopic examination of the spun urine sediment (red blood cell (RBC)/ high power field \[hpf\]) and by urine dipstick.
Post-Baseline Category: Negative
Group
Value
95% CI
DBT Period: Placebo
0
DBT Period: Cemdisiran
4
Post-Baseline Category: Small
Group
Value
95% CI
DBT Period: Placebo
2
DBT Period: Cemdisiran
11
Post-Baseline Category: Moderate
Group
Value
95% CI
DBT Period: Placebo
2
DBT Period: Cemdisiran
4
Post-Baseline Category: Large
Group
Value
95% CI
DBT Period: Placebo
4
DBT Period: Cemdisiran
1
Number of Participants With Adverse Events (AEs)Secondary· Up to 126 weeks
An AE is any untoward medical occurrence in a participant or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Group
Value
95% CI
DBT Period: Placebo
8
DBT Period: Cemdisiran
19
DBT Period: Placebo + OLE Period: Cemdisiran
8
DBT Period: Cemdisiran + OLE Period: Cemdisiran
22
All Cemdisiran
30
Adverse events — posted to ClinicalTrials.gov
Time frame: DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
DBT Period: Placebo
Serious: 0/9 (0%)
Deaths: 1/9
DBT Period: Cemdisiran
Serious: 1/22 (5%)
Deaths: 1/22
DBT Period: Placebo + OLE Period: Cemdisiran
Serious: 3/8 (38%)
Deaths: 0/8
DBT Period: Cemdisiran + OLE Period: Cemdisiran
Serious: 2/22 (9%)
Deaths: 1/22
All Cemdisiran
Serious: 5/30 (17%)
Deaths: 2/30
Serious adverse events (5 terms)
Reaction
System
DBT Period: Placebo
DBT Period: Cemdisiran
DBT Period: Placebo + OLE …
DBT Period: Cemdisiran + O…
All Cemdisiran
Cardiopulmonary failure
Cardiac disorders
—
—
—
—
—
Cholecystitis acute
Hepatobiliary disorders
—
—
—
—
—
Helicobacter gastritis
Infections and infestations
—
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
—
End stage renal disease
Renal and urinary disorders
—
—
—
—
—
Other adverse events (122 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07154745 — A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hem
· Phase 3
· recruiting
NCT06541704 — A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult
· Phase 3
· recruiting
NCT05744921 — A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With P
· Phase 3
· recruiting
NCT05131204 — Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment
· Phase 3
· terminated
NCT05133531 — A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With
· Phase 3
· recruiting
Other recruiting trials for IgA Nephropathy (IgAN)
Currently open trials in the same condition.
NCT07389499 — A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediate
· EARLY_PHASE1
· recruiting
NCT07305974 — A Phase IIa Clinical Study of RG002C0106 Injection in Subjects With Primary IgA Nephropathy
· Phase 2
· recruiting
NCT06676579 — Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
· Phase 2
· recruiting
NCT07056595 — Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial
· NA
· recruiting
NCT06819826 — A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria
· Phase 3
· recruiting
Other Alnylam Pharmaceuticals trials
Trials by the same sponsor.
NCT07535606 — A Study to Evaluate ALN-4915 in Adult Healthy Volunteers
· Phase 1
· recruiting
NCT07463846 — A Study to Evaluate ALN-2232 in Participants With Obesity
· Phase 1, PHASE2
· recruiting
NCT07223203 — TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidos
· Phase 3
· recruiting
NCT07465224 — A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus
· Phase 2
· recruiting
NCT07358078 — DemonsTTRate: A Global, Observational, Multicenter, Long-term Study of Patients With ATTR-CM in a Real-World Setting
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alnylam Pharmaceuticals
Last refreshed: 9 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03841448.