RANDOMISED PILOT TRIAL OF MYFORTIC FOR THE TREATMENT OF PRIMARY PROTEINURIC GLOMERULONEPHRITIS. - GloMY - Proteinuria in glomerulonephritis : Myfortic

Phase 1

• Conditions: Primary Proteinuric Glomeruolnephritis Focal segmental glomeruloscerosis and IgA nephropathy; MedDRA version: 14.1Level: PTClassification code 10067757Term: Focal segmental glomerulosclerosisSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 14.1Level: PTClassification code 10021263Term: IgA nephropathySystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2009-016003-26-GB
• Lead Sponsor: HB NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 <130/80 mmHg
3.If female and of childbearing potential, must:
•Not be pregnant or breastfeeding
•Agree to avoid pregnancy during and for 6 weeks following the last dose of study treatment
4.If male with a partner of childbearing potential, must:
•Agree to use adequate, medically approved, contraceptive precautions during and for 6 weeks following the last dose of study treatment

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Age <18 years
2.Secondary causes of FSGS
3.Secondary IgAN
4.Deteriorating renal function >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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br><br>;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.<br><br>To determine treatment safety.<br>;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.