Proteinuria in Glomerulonephritis: Myfortic® (GloMY)

Phase 3

Completed

• Conditions: Renal; primary proteinuric glomerulonephritis; Urological and Genital Diseases; Unspecified nephritic syndrome

• Registration Number: ISRCTN11937028
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-27
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with new onset biopsy proven (within last year) primary FSGS with albumin <30g/dl OR patients with primary IgAN with biopsy findings E1 and T<2 using the Oxford classification and a minimum of 8 glomeruli in the biopsy
2. Proteinuria (Protein Creatinine Ratio, PCR>150) following at least 4 weeks treatment with maximal blood pressure lowering therapy (to include angiotensin blockade) to target blood pressure <125/75 mmHg
3. If female and of childbearing potential, must not be pregnant or breastfeeding, and 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.

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 =140/80 mmHg)
7. Previous treatment with immunosuppression therapies
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. Inability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified