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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
Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
Urine protein creatinine ratio ≥1 g/24hr
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Nefigard Trial Summary

This trial is testing a new drug to see if it can help people with Immunoglobulin A nephropathy (a kidney disease) who are at risk of progressing to end-stage renal disease, and who are already taking the maximum tolerated doses of other drugs.

Eligible Conditions
  • IgA Nephropathy

Nefigard Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Nefigard Trial 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

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

Nefigard 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
2018
Completed Phase 3
~370

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

Frequently Asked Questions

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

How does Nefecon compare to other options in terms of safety?

"Nefecon received a safety score of 3 because it has reached Phase 3 in clinical trials. This indicates that not only is there some evidence supporting its efficacy, but also that there is ample evidence indicating that it is safe."

Answered by AI

How many more people can join this trial?

"As of December 10th 2021, this clinical trial is no longer recruiting patients. If you are interested in other research studies, there are currently 501 trials for iga glomerulonephritis and 32 for Nefecon admitting new participants."

Answered by AI

What are the most similar medical trials to Nefecon?

"Currently, there are 32 trials in progress for Nefecon. 10 of them are in Phase 3. Although the majority of studies for Nefecon are based in Xi'an, Shaanxi, there are 992 locations running studies for this treatment."

Answered by AI

What conditions does Nefecon help ameliorate?

"Nefecon is an effective medication for acute coryza and can also help patients with proteinuria, nasal congestion, and crohn disease."

Answered by AI
~56 spots leftby Mar 2025