The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 6 October 2015
• Main ID: NCT01738035
• Date of registration: 25/07/2012
• Prospective Registration: Yes
• Primary sponsor: Pharmalink AB
• Public title: The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease NEFIGAN
• Scientific title: A Multicentre, Interventional Treatment, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in Primary IgA Nephropathy Patients at Risk of End-stage Renal Disease
• Date of first enrolment: December 2012
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01738035
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Czech Republic, Denmark, Finland, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Contacts

• Name: Alex Mercer, PhD
• Affiliation: Pharmalink AB, Stockholm, Sweden

• Name: Bengt Fellström, MD, PhD
• Affiliation: Professor of Medicine Department of Medical Sciences, Renal Medicine Uppsala University Hospital, Sweden

Key inclusion & exclusion criteria

Screening Inclusion Criteria:

1. Female or male patients =18 years

2. Biopsy-verified IgA nephropathy

3. Urine protein creatinine ratio =0.5 g/g OR urine protein =0.75 g/24hr

4. Estimated GFR (using the CKD-EPI formula) OR measured GFR =50 mL/min per 1.73 m2 OR
=45 mL/min per 1.73m2 for patients on a maximum recommended or maximum tolerated dose
of an ACEI and/or ARB

5. Willing to change antihypertensive medication regimen if applicable

6. Willing and able to give informed consent

Screening Exclusion Criteria:

1. Secondary forms of IgA nephropathy as defined by the treating physician (for example,
Henoch-Schönlein purpura patients and those with associated alcoholic cirrhosis)

2. Presence of crescent formation in =50% of glomeruli assessed on renal biopsy

3. Kidney transplanted patients 4. Severe gastrointestinal disorders (including peptic
ulcer disease and inflammatory bowel disease) which may impair drug effect, or other
conditions which could modify the effect of the trial drug as judged by the
Investigator

4. Patients currently treated with systemic immunosuppressive or systemic corticosteroid
drugs (excluding topical or nasal steroids) or have been previously treated for more
than one week within the last 24 months.

5. Patients currently treated chronically (daily dosing) with inhaled corticosteroid
drugs or have previously been treated chronically for more than one month within the
last 12 months

6. Patients previously treated with immunosuppressive or systemic corticosteroids for
the treatment of IgA nephropathy

7. Patients unable to take oral medication or intolerant to budesonide or other
corticosteroid preparations

8. Patients with known allergy or intolerance to ACEI, ARB or to any component of the
trial drug formulation

9. Patients with acute or chronic infectious disease incl. hepatitis, HIV positive
patients and patients with chronic urinary tract infections

10. Severe liver disease according to the discretion of the Investigator

11. Patients with Type 1 or 2 diabetes

12. Patients with uncontrolled cardiovascular disease as judged by the Investigator

13. Patients with current malignancy or history of malignancy during the last three years

14. For women only; pregnant or breast feeding or unwilling to use adequate contraception
during the trial (only women of child bearing potential)

Randomization Inclusion Criteria:

1. Completion of the Run-in Phase

2. Urine protein creatinine ratio =0.5 g/g OR urine protein =0.75 g/24hr

3. eGFR =45 mL/min per 1.73 m2 using CKD-EPI formula OR measured GFR =45 mL/min per 1.73
m2

Randomization Exclusion Criteria:

1. Unacceptable blood pressure defined as a systolic value >160 mm Hg or diastolic >100
mm Hg

2. eGFR (CKD-EPI) loss >30% over the entire duration of the Run-in Phase

3. For women only; pregnant or breast feeding or unwilling to use adequate contraception
during the trial (only women of child bearing potential)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Primary IgA Nephropathy

Intervention(s)

Drug: NEFECON

Other: Placebo

Primary Outcome(s)

Change from baseline in urine protein creatinine ratio [Time Frame: 9 months]

Secondary Outcome(s)

Change from baseline in 24 hour albuminuria [Time Frame: 9 months]

Change from baseline in estimated GFR [Time Frame: 9 months]

Change from baseline in urine albumin creatinine ratio [Time Frame: 9 months]

Secondary ID(s)

Nef-202

2012-001923-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors