A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.

Phase 1

• Conditions: Primary IgA nephropathy patients at risk of developing end stage renal disease; MedDRA version: 20.0Level: LLTClassification code 10069341Term: Berger's diseaseSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-004902-16-IT
• Lead Sponsor: CALLIDITAS THERAPEUTICS AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-20
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Patients must meet all of the following inclusion criteria at screening to be eligible for admission into the study:
1. Female or male patients =18 years of age;
2. Diagnosed IgAN with biopsy verification within the past 10 years;
3. On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or MTD according to the 2012 KDIGO guidelines for the 3 months prior to randomization (see Appendix D). In this instance, a stable dose is defined as doses within 25% of the dose at randomization. Patients on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) below the maximum allowed dose or MTD according to the 2012 KDIGO guidelines will be permitted into the study if an attempt to reach the maximum allowed dose or MTD has been performed21 or if
such attempt is deemed unsafe for the patient by the Investigator; and Note: It is recommended that patients achieve a target systolic blood pressure <125 mmHg and target diastolic blood pressure <75 mmHg according to the 2012 KDIGO guidelines.
4. Willing and able to provide written informed consent at screening. In addition, patients must meet the following inclusion criteria before randomization into the study:
5. Proteinuria based on 2 consecutive measurements (24-hour urine sampling) after informed consent, separated by at least 2 weeks and calculated by the central laboratory. Both samples of the same parameter must show either of the following:
o Proteinuria =1 g per day (=1000 mg per day) in 2 consecutive
measurements, or
o UPCR =0.8 g/gram (=90 mg/mmol) in 2 consecutive measurements; and
6. eGFR >=35 mL/min per 1.73 m2 and =90 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, confirmed by the central laboratory at Study Visit 1 or Study Visit 3.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 328
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

Please refer to the protocol due to characters number limitation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified