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Immunosuppressant

Nefecon for IgA Nephropathy (Nefigard Trial)

Phase 3
Waitlist Available
Research Sponsored by Calliditas Therapeutics AB
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 up to 2 years
Awards & highlights
Pivotal Trial

Summary

This trial tests Nefecon, a daily oral medication, for patients with primary IgAN who are not improving with standard treatments. The drug aims to reduce kidney inflammation and prevent further damage.

Eligible Conditions
  • IgA Nephropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Proteinuria, measured as Urine Protein to creatinine ratio (UPCR).
Renal function measured as estimated glomerular filtration rate (eGFR)
Secondary study objectives
Renal function
The incidence of treatment-emergent adverse events.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NefeconExperimental Treatment1 Intervention
Nefecon 16 mg once daily by mouth for 9 months.
Group II: Placebo oral capsulePlacebo Group1 Intervention
Placebo oral capsule once daily by mouth for 9 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nefecon
2022
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

Calliditas Therapeutics ABLead Sponsor
9 Previous Clinical Trials
821 Total Patients Enrolled
Krassimir Mitchev, MDStudy DirectorCalliditas AB
1 Previous Clinical Trials
~51 spots leftby Nov 2025
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