Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function (Acthar)
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|ClinicalTrials.gov Identifier: NCT03644771|
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : February 5, 2020
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.
|Condition or disease||Intervention/treatment|
|Decrease of Proteinuria With H.P. Acthar Gel and Its Effects on Clinical and Podocyte Function||Drug: Acthar|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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|
|Actual Study Start Date :||January 25, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Drug: Acthar
4 treatment periods of 3 months each with 20 units biweekly, 40 units biweekly, and 80 units biweekly, with a tapering period to no drug for the fourth 3 month period. Then one year f/u.
- level of proteinuria [ Time Frame: 2 years ]clinical response and basic science data for podocyte function
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644771
|United States, Massachusetts|
|Greater Boston Medical Associates 211 West St.||Recruiting|
|Milford, Massachusetts, United States, 01757|
|Contact: Martin L Gelman, MD 508-473-2022 firstname.lastname@example.org|
|Sub-Investigator: Sanja Sever, PhD|