Decrease of Proteinuria With H.P. Acthar Gel and Its Effects on Clinical and Podocyte Function Clinical Trial
Official title:
Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function
Patients with proteinuria to start treatment with Acthar and watch a variety of clinical
parameters with a goal of decreasing proteinuria between 50-100% over a period of nine months
with every 3 months increasing the dose of medication until a decrease of either 50- 100 % of
protein excretion is achieved.
In addition addition podocyte function will be assessed monthly by measuring suPar levels,
tnf alpha, podocyte/creatinine levels as well as podocyte function studies.
Patients with proteinuria/nephrotic syndrome with albumin/creatinine ratios of 50 or 24 hour
urine protein of 500mg or greater will receive increasing doses of H.P. Acthar Gel starting
with 20 units weekly or biweekly for 3 months after a one month washout observational period.
The second three month period calls for 40 units biweekly, and the third three month period
uses 80 units biweekly observing if the reduction in proteinuria reaches a goal of 50-100%.
Pre study clinical parameters include Cbc diff, cmp, lipid with ldl, cortisol, acth, 24 hour
urine for creatinine and protein, urine albumin/creatinine ratio, protein/creatinine ratio,
bone density, hgba1c, weight , blood pressure, vital signs, and overall health questionaire.
Monthly cbc, cmp, prot/creat, alb/creat ratios, and one red top tube and one 50cc urine
container to go to MGH Charlestown for basic podocyte studies. The fourth -3 month
observational period will be with tapering to stopping the dose of Acthar and following the
same monthly and the pre study parameters.
A second year of observation will continue checking patients every other month for one year
to determine the length of protein decrement observed in the first year.
The study will conclude after the second year of drug free followup.
Biomarker studies of podocyte function will be done for the full 2 year period.
Final data analysis will conclude after the 2 year period of observation.
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