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Immunosuppressant
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) 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 over 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A: Ratio of Urine Protein to Creatinine Ratio (UPCR) at 9 Months Compared to Baseline
Part B: Time-weighted Average of Estimated Glomerular Filtration Rate (eGFR)
Secondary study objectives
Part A: Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months
Part A: Ratio of eGFR at 12 Months
Part A: Ratio of eGFR at 9 Months
+8 moreSide effects data
From 2023 Phase 3 trial • 365 Patients • NCT0364396515%
Edema peripheral
12%
Hypertension
12%
Muscle spasms
11%
Acne
10%
Headache
9%
Nasopharyngitis
7%
Dyspepsia
7%
Arthralgia
5%
Insomnia
5%
Diarrhea
5%
Upper respiratory tract infection
5%
Weight increased
5%
Fatigue
5%
Rash
4%
Nausea
1%
Corona virus infection
1%
Pneumonia
1%
Erysipelas
1%
Acute kidney injury
1%
Renal impairment
1%
Nephrotic syndrome
1%
Hypertensive urgency
1%
Post thrombotic syndrome
1%
Chest pain
1%
Face oedema
1%
Generalised oedema
1%
Oedema peripheral
1%
Pulmonary embolism
1%
Dyspnoea
1%
Gastritis haemorrhagic
1%
Pancreatitis acute
1%
Cardiac failure congestive
1%
Abortion spontaneous
1%
Rash generalised
1%
Meningioma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nefecon
Placebo Oral Capsule
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
10 Previous Clinical Trials
881 Total Patients Enrolled
Krassimir Mitchev, MDStudy DirectorCalliditas AB
1 Previous Clinical Trials