Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change)
Brief description of study
A sign of the kidney disease is the presence of too much protein in your urine. The purpose of this study is to evaluate if the investigational study drug Abatacept can decrease the amount of protein in the urine of affected patients and improve the kidney disease beyond the treatment one have received or are already receiving.
Detailed description of study
You will randomly (by chance) be chosen to receive one of two intravenous (delivered in the vein) treatments: abatacept (the investigational study drug) or placebo (Normal Saline or 5% Dextrose in Water) for 4 months (Treatment Period 1) and then switch to the other treatment (placebo or abatacept) for another 4 months (Treatment Period 2). This means that you will receive abatacept in one period and placebo in the other. This study is “blinded”. Neither you nor your study doctor or study coordinator will know what treatment (abatacept or placebo) you are receiving during Period 1 or Period 2. After the completion of the 8 months of blinded treatment, you may choose to receive treatment with intravenous abatacept for an additional 6 months in an open label extension (OLE) period. This choice will be based on how you and the study doctor feel after having a discussion about the risks and benefits of the study. There will be assessment for early escape during Period 2. If your disease worsens during Period 2 (the amount of protein in your urine has increased, for example) your study doctor will remove you from Period 2 and discuss entering you into the OLE period so that you may receive treatment with abatacept.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Minimal change disease,Focal segmental glomeruloscler,minimal
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Age: Between 18 Years - 100 Years
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Gender: All
Updated on
13 Jul 2023.
Study ID: 826208
