Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy MedDRA version: 14.1 Level: PT Classification code 10067757 Term: Focal segmental glomerulosclerosis System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Myfortic
Product Name: Myfortic 360mg Tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: mycophenolic acid
CAS Number: 24280-93-1
Other descriptive name: mycophenola
Sponsors
UHB NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: . Inclusion Criteria 1. Patients with new onset biopsy proven (within last year) primary FSGS with albumin lss than the normal laboratory reference range OR patients with primary IgAN with biopsy findings E1 or M1 using the Oxford classification (see Appendix 2) and a minimum of 8 glomeruli in the biopsy AND 2. Proteinuria (Protein Creatinine Ratio, PCR>100mg/mmol or ACR>66mg/mmol) following at least 4 weeks treatment with maximal blood pressure lowering therapy (to include angiotensin blockade) to target blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Age 20µmol/l each week for 3 weeks or more 5. estimated Glomerular Filtration Rate (eGFR) <20 ml/min (using modification of diet in renal disease (MDRD) equation) 6. Poor blood pressure control (e.g. blood pressure =140/90 mmHg) 7. Previous treatment with immunosuppression therapies for renal disease 8. Unable to receive immunosuppression treatments due to malignancy or active infection 9. Patients with systemic infection unless specific anti-infective therapy is employed 10. Diabetes 11. Known to have Hepatitis B or C 12. Known to be HIV positive 13. Neutropenia 14. Inability to give informed consent 15. Greater than 2 weeks of steroid therapy for renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility of running a full-scale randomised phase 3 trial of Myfortic plus short course steroids (prednisolone) versus standard care in patients with Focal segmental glomerulosclerosis (FSGS) or IgA nephropathy and to obtain preliminary comparative data on the efficacy of Myfortic plus short course steroids in inducing sustained response in patients with FSGS or IgAN. ;Secondary Objective: To determine preliminary data on the effectiveness of myfortic plus short course steroids in inducing sustained remission, reducing proteinuria and preventing progression of chronic kidney disease. To determine treatment safety. ;Primary end point(s): The primary measure of efficacy will be the proportion of patients achieving complete or partial remission by 24 weeks sustained (relapse free) for 12 months. | — |
Countries
United Kingdom
Outcome results
None listed