← Back to Search

siRNA

Cemdisiran for IgA Nephropathy

Phase 2
Waitlist Available
Research Sponsored by Alnylam Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 240 weeks
Awards & highlights

Study Summary

This trial will test if cemdisiran can help reduce proteinuria in adults with IgAN who are still excreting high levels of protein despite standard care.

Eligible Conditions
  • Immunoglobulin A Nephropathy
  • Berger's Disease
  • IgA Nephropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 240 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 240 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32
Secondary outcome measures
Change From Baseline in UPCR as Measured in a Spot Urine at Week 32
Number of Participants With Adverse Events (AEs)
Number of Participants With Change From Baseline in Hematuria at Week 32
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Double-Blind Treatment (DBT) Period: CemdisiranExperimental Treatment1 Intervention
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.
Group II: DBT Period: Cemdisiran to Open-Label Extension (OLE) Period: CemdisiranExperimental Treatment1 Intervention
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.
Group III: DBT Period: PlaceboPlacebo Group1 Intervention
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.
Group IV: DBT Period: Placebo to OLE Period: CemdisiranPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemdisiran
2020
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
73 Previous Clinical Trials
14,987 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,782 Previous Clinical Trials
8,066,285 Total Patients Enrolled

Media Library

Cemdisiran (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT03841448 — Phase 2
Immunoglobulin A Nephropathy Research Study Groups: Double-Blind Treatment (DBT) Period: Cemdisiran, DBT Period: Placebo, DBT Period: Cemdisiran to Open-Label Extension (OLE) Period: Cemdisiran, DBT Period: Placebo to OLE Period: Cemdisiran
Immunoglobulin A Nephropathy Clinical Trial 2023: Cemdisiran Highlights & Side Effects. Trial Name: NCT03841448 — Phase 2
Cemdisiran (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03841448 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation stand as a precedent for other similar trials?

"Currently, 6 clinical trials for Cemdisiran are taking place in 41 cities and 20 countries. Alnylam Pharmaceuticals initiated the first trial of this drug back in 2019 when 31 patients were enrolled to complete Phase 2 approval stages; since then, 18323 additional tests have been conducted."

Answered by AI

Does the criteria for this study encompass individuals who have surpassed sixty years of age?

"According to the eligibility criteria for this trial, only individuals aged 18-65 can participate. However, 48 trials are available for those below 18 years of age and 462 clinical studies cater to patients beyond 65."

Answered by AI

How widely dispersed are the locales conducting this scientific trial across the state?

"Currently, this research trial is recruiting at 4 centres: Vancouver, Brampton and Toronto are notable among them. Participants should strive to choose the closest clinic so as to lessen travel requirements if they join up."

Answered by AI

Am I eligible to participate in this investigation?

"In order to be considered for the research, potential participants must have glomerulonephritis and fit within the specified age criteria (18-65). Currently, 31 individuals are being sought."

Answered by AI

What additional scrutiny has Cemdisiran been subject to?

"At the moment, 6 research studies revolving around Cemdisiran are currently underway. 3 of these trials have entered Phase 3 and there are 84 sites across the globe conducting experiments for this drug. The majority of investigations take place in Whittier, California."

Answered by AI

Has Cemdisiran been officially sanctioned by the FDA?

"Cemdisiran has only been tested in Phase 2 trials, so its safety rating is a conservative 2. This means that while there are data affirming the drug's security profile, no studies have yet proven it to be efficacious."

Answered by AI

Is this survey actively seeking new participants?

"At present, this medical trial is not actively seeking out participants. It was first published on April 24th 2019 and last updated November 7th 2022. However, there are currently 497 glomerulonephritis trials admitting new patients and 6 Cemdisiran studies that are still recruiting individuals for participation."

Answered by AI

What is the current enrollment rate of this scientific experiment?

"Currently, this trial has concluded their recruitment phase. It was initially posted on April 24th 2019 and last updated November 7th 2022. For those looking for other medical studies, there are 497 trials pertaining to glomerulonephritis and 6 investigations concerning Cemdisiran that remain open to patient recruitment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
2019. "A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03841448.
~6 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top