Randomised pilot trial of Myfortic® for the treatment of primary proteinuric glomerulonephritis

niversity Hospitals Birmingham NHS Foundation Trust (UK)0 个研究点目标入组 100 人开始时间: 2010年5月27日最近更新: 2016年12月19日

适应症

试验速览

暂无简介。

•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.

•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

发起方

niversity Hospitals Birmingham NHS Foundation Trust (UK)