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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01738035
Other study ID # Nef-202
Secondary ID 2012-001923-11
Status Completed
Phase Phase 2
First received July 25, 2012
Last updated September 23, 2015
Start date December 2012
Est. completion date September 2015

Study information

Verified date September 2015
Source Pharmalink AB
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

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


Intervention

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:
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.

Locations

Country Name City State
Belgium University Hospital of Antwerp Antwerp
Belgium Imelda Hospital Bonheiden
Belgium Ghent University Hospital Ghent
Belgium University Hospitals Leuven Leuven
Belgium Heilig Hartziekenhuis Roeselare-Menen Roeselare
Czech Republic University Hospital Olomouc
Czech Republic Charles University & General University Hospital Prague
Czech Republic Institut klinické a experimentální medicíny Prague
Denmark Rigshospitalet Copenhagen
Denmark Herlev Hospital Herlev
Denmark Odense University Hospital Odense
Finland Helsinki University Central Hospital Helsinki
Finland Tampere University Hospital Tampere
Finland Turku University Central Hospital Turku
Germany RWTH Aachen Aachen
Germany Klinikum Augsburg Augsburg
Germany Charité Hospital Berlin
Germany Charité-Virchow Clinic Berlin
Germany Vivantes Klinikum im Friedrichshain Berlin
Germany Klinikum-Bremen-Mitte Bremen
Germany University Hospital Carl Gustav Carus Dresden
Germany Studienzentrum Karlstrasse Düsseldorf
Germany Universitätsklinikum Erlangen Erlangen
Germany Universitätsmedizin Göttingen Göttingen
Germany University Hospital Heidelberg
Germany University of Jena Jena
Germany Universitätsklinikum Magdeburg Magdeburg
Germany Universität München Munich
Germany Universitätsklinikum Münster Münster
Germany Universitätsklinikum Regensburg Regensburg
Germany Deutsche Klinik für Diagnostik Wiesbaden
Germany Würzburg University Hospital Würzburg
Italy Policlinico di Bari Bari
Italy Azienda Ospedaliera G. Brotzu Cagliari
Italy Ospedale A Manzoni Lecco
Italy Bassini Hospital Milano
Italy Ospedale S. G. Bosco Torino
Italy Belcolle Hospital Viterbo
Netherlands University Medical Center Leiden
Spain Fundación Puigver Barcellona
Spain Hospital Universitario Vall d'Hebron Barcellona
Spain 12 de Octubre Hospital Madrid
Spain Fundación Jimenez Diaz Hospital Madrid
Spain Hospital Universitario Gregorio Marañon Madrid
Sweden Central sjukhuset Karlstad
Sweden Karlstad Central Hospital Karlstad
Sweden University Hospital Linköping
Sweden Danderyds Hospital Stockholm
Sweden Karolinska University Hospital Stockholm
Sweden Uppsala University Hospital Uppsala
United Kingdom Belfast City Hospital Belfast
United Kingdom Ulster Hospital Belfast
United Kingdom Royal Derby Hospital Derby
United Kingdom Edinburgh Royal Infirmary Edinburgh
United Kingdom Western Infirmary Glasgow
United Kingdom The Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom Leicester General Hospital Leicester
United Kingdom James Cook University Hospital Middlesbrough

Sponsors (1)

Lead Sponsor Collaborator
Pharmalink AB

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline in urine protein creatinine ratio 3-12 months No
Other Change in urine albumin creatinine ratio 3-12 months No
Other Change from baseline in 24 hour albuminuria 3-12 months No
Other Change from baseline in estimated GFR 3-12 months No
Primary Change from baseline in urine protein creatinine ratio 9 months No
Secondary Change from baseline in urine albumin creatinine ratio 9 months No
Secondary Change from baseline in 24 hour albuminuria 9 months No
Secondary Change from baseline in estimated GFR 9 months No
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