Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03644771
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2018-08-22
Brief Title:
Experience With HP Acthar Gel Treatment of Patients With Nephrotic SyndromeProteinuria Due to Various Etiologies and Its Effect on Podocyte Function
Sponsor:
Greater Boston Medical Associates
Organization:
Greater Boston Medical Associates
Study Overview
Official Title:
Experience With HP Acthar Gel Treatment of Patients With Nephrotic SyndromeProteinuria Due to Various Etiologies and Its Effect on Podocyte Function
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Acthar
Brief Summary:
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 podocytecreatinine levels as well as podocyte function studies
In addition addition podocyte function will be assessed monthly by measuring suPar levels tnf alpha podocytecreatinine levels as well as podocyte function studies
Detailed Description:
Patients with proteinurianephrotic syndrome with albumincreatinine ratios of 50 or 24 hour urine protein of 500mg or greater will receive increasing doses of HP 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 albumincreatinine ratio proteincreatinine ratio bone density hgba1c weight blood pressure vital signs and overall health questionaire Monthly cbc cmp protcreat albcreat 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
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 albumincreatinine ratio proteincreatinine ratio bone density hgba1c weight blood pressure vital signs and overall health questionaire Monthly cbc cmp protcreat albcreat 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None