Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function (Acthar)

• ClinicalTrials.gov Identifier: NCT03644771
• Recruitment Status: Recruiting
• First Posted: August 23, 2018
• Last Update Posted: February 5, 2020
• Sponsor: Greater Boston Medical Associates
• Collaborator: Massachusetts General Hospital
• Information provided by (Responsible Party): Greater Boston Medical Associates

Tracking Information

• First Submitted Date: August 22, 2018
• First Posted Date: August 23, 2018
• Last Update Posted Date: February 5, 2020
• Actual Study Start Date: January 25, 2017
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 22, 2018)

level of proteinuria [ Time Frame: 2 years ]

clinical response and basic science data for podocyte function

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function
• 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

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, podocyte/creatinine levels as well as podocyte function studies.

Detailed Description

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
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

one red top tube of blood per month one 50cc urine container per month

• Sampling Method: Probability Sample
• Study Population: Patients 18-75 with proteinuria as described.
• Condition: Decrease of Proteinuria With H.P. Acthar Gel and Its Effects on Clinical and Podocyte Function

Intervention

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.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 22, 2018): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2021
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• patients with proteinuria as above. patients with controlled conditions below are candidates.

Exclusion Criteria:

• uncontrolled hypertension,diabetes mellitus, congestive heart failure, coronary artery disease, peripheral vascular disease.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03644771
• Other Study ID Numbers: 20150814
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Yes if clinically necessary otherwise at end of study

• Responsible Party: Greater Boston Medical Associates
• Study Sponsor: Greater Boston Medical Associates
• Collaborators: Massachusetts General Hospital
• Investigators: Not Provided
• PRS Account: Greater Boston Medical Associates
• Verification Date: February 2020