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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01738035
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Calliditas Therapeutics AB

Tracking Information
First Submitted Date  ICMJE July 25, 2012
First Posted Date  ICMJE November 30, 2012
Last Update Posted Date September 24, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
Change from baseline in urine protein creatinine ratio [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • Change from baseline in urine albumin creatinine ratio [ Time Frame: 9 months ]
  • Change from baseline in 24 hour albuminuria [ Time Frame: 9 months ]
  • Change from baseline in estimated GFR [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 29, 2012)
  • Change from baseline in urine protein creatinine ratio [ Time Frame: 3-12 months ]
  • Change in urine albumin creatinine ratio [ Time Frame: 3-12 months ]
  • Change from baseline in 24 hour albuminuria [ Time Frame: 3-12 months ]
  • Change from baseline in estimated GFR [ Time Frame: 3-12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease
Official Title  ICMJE 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
Brief Summary The objective of the study is to evaluate efficacy and safety of two different doses of NEFECON in the treatment of patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease, under rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).
Detailed Description

NEFECON is an add-on treatment to other medications for nephropathy symptoms and kidney function, including ACEI and/or ARBs. Rigorous blood pressure control will be achieved over a 6-month Run-in Phase in which ACEI and/or ARB will be dosed to target a blood pressure of <130/80 mm Hg and UPCR <0.5 g/g. Patients who complete the Run-in Phase, and despite optimized ACEI and/or ARB therapy, have a UPCR ≥0.5 g/g OR urine protein ≥0.75 g/24hr will be eligible for randomization and entry into the treatment phase of the trial. Patients will remain on their ACEI and/or ARB dosing regimen for the duration of the trial.

Patients entering the treatment phase will be administered NEFECON (8 mg/day OR 16 mg/day) OR placebo for a phase of 9 months. A 3-month follow-up phase will follow on from the treatment phase, of which the first 2 weeks will be used to taper the dose of those patients that received 16 mg/day dosing to 8 mg/day, with the placebo and 8 mg/day groups receiving placebo to retain blinding.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary IgA Nephropathy
Intervention  ICMJE
  • Drug: NEFECON
    All patients will receive a maximum recommended daily dose of an ACEI and/or ARB (or maximum tolerated dose not exceeding the maximum recommended daily dose) for the duration of the treatment and follow-up phases.
    Other Name: Budesonide modified-released capsules (4 mg/capsule)
  • Other: Placebo
    All patients will receive a maximum recommended daily dose of an ACEI and/or ARB (or maximum tolerated dose not exceeding the maximum recommended daily dose) for the duration of the treatment and follow-up phases.
Study Arms  ICMJE
  • Experimental: NEFECON 8 mg/day
    NEFECON 8 mg/day (2 active + 2 placebo capsules daily) for 9 months
    Intervention: Drug: NEFECON
  • Experimental: NEFECON 16 mg/day
    NEFECON 16 mg/day (4 active capsules daily) for 9 months
    Intervention: Drug: NEFECON
  • Placebo Comparator: Placebo
    Placebo (4 placebo capsules daily) for 9 months
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2015)
150
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2012)
90
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   Denmark,   Finland,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01738035
Other Study ID Numbers  ICMJE Nef-202
2012-001923-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Calliditas Therapeutics AB
Study Sponsor  ICMJE Calliditas Therapeutics AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bengt Fellström, MD, PhD Professor of Medicine Department of Medical Sciences, Renal Medicine Uppsala University Hospital, Sweden
Study Director: Alex Mercer, PhD Pharmalink AB, Stockholm, Sweden
PRS Account Calliditas Therapeutics AB
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP