NCT01386554|CompletedPhase 4Results

Acthar for Treatment of Proteinuria in Membranous Nephropathy Patients

CHART

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of H.P. Acthar Gel (Acthar) in Treatment-Resistant Subjects With Persistent Proteinuria and Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy (iMN)

Mallinckrodt ClinicalTrials.gov

Compare

2 other identifiers

QSC01-MN-01Control No. 166679

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredJul 2011

StartedAug 2011

CompletionMay 2017

Brief Summary

The purpose of this study is to provide nephrologists with additional clinical evidence regarding the efficacy and safety of Acthar in subjects with treatment-resistant idiopathic membranous nephropathy. Approximately sixty (60) subjects will be randomized in this double-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar and Placebo administered 2 times per week for a 24-week treatment period followed by a 24-week observation period. The primary objective of this study is to assess the proportion of treatment-resistant subjects (defined as subjects who either have had no response or have suffered a relapse after achieving a partial response to their most recent standard treatment regimen) who have a complete or partial remission of proteinuria in nephrotic syndrome due to idiopathic membranous nephropathy after 24 weeks of treatment.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach

5 countries

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.8 years study duration

First Submitted

Initial submission to the registry

June 29, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed

1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2016

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2017

Completed

11 months until next milestone

Results Posted

Study results publicly available

March 26, 2018

Completed

Last Updated

November 20, 2019

Status Verified

April 1, 2018

Enrollment Period

5.3 years

First QC Date

June 29, 2011

Results QC Date

December 15, 2017

Last Update Submit

November 18, 2019

Conditions

Proteinuria Idiopathic Membranous Nephropathy

Keywords

H.P. Acthar GelActharnephrotic syndromeidiopathic membranous nephropathyproteinuria

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Complete or Partial Remission in Proteinuria at 24 Weeks
The participant's response was considered the average of the two PCR values from the 24-hour urine collected at Visit 8 (Week 24). Urine protein creatinine ratio (uPCR) was used to assess remission (partial and complete). Complete remission = uPCR \< 0.3 g/g; partial remission = uPCR \< 50% of baseline uPCR and \> 0.3 g/g but \< 3.0 g/g.
At Visit 8 (Week 24)

Secondary Outcomes (1)

Percentage of Participants With Sustained Remission
At Visit 9 (Week 28)

Study Arms (3)

80 U Acthar

EXPERIMENTAL

Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) two times per week

Drug: Repository Corticotropin Injection

1.0 mL Placebo

PLACEBO COMPARATOR

Placebo (1.0 mL) two times per week

Drug: Placebo

40 U Acthar

EXPERIMENTAL

Acthar (Repository Corticotropin Injection) 40 U (1.0 mL) two times per week

Drug: Repository Corticotropin Injection

Interventions

Repository Corticotropin InjectionDRUG

Acthar given SC for 6 months

Also known as: H.P. Acthar Gel, ACTH Gel, ACTH

40 U Acthar80 U Acthar

PlaceboDRUG

Placebo contains the same inactive ingredients as that used for H.P. Acthar Gel without the API. Placebo given SC for 6 months (80 U two times a week).

1.0 mL Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

Male or female subjects ≥18 years of age, at screening Visit 1:
a. If potential subjects are \>75 years of age, discussion between the investigator and the Medical Monitor must take place;
Body mass index ≤40 kg/m2, at screening Visit 1;
A history of nephrotic syndrome due to iMN as confirmed by documented results from a renal biopsy performed within 4 years prior to screening Visit 1:
a. If a biopsy has been performed between 4-8 years prior to screening, and if the subject has no signs or symptoms of diabetes or other clinical diagnoses that could suggest a change in renal histology in the opinion of the investigator and the Medical Monitor, the subject is eligible.
Renal target disease requirements:
Total urine protein of ≥3.0g (≥3000mg) from the 24-hour urine returned at Visit 1A, AND.
An estimated glomerular filtration rate (eGFR) value \>25mL/min/1.73m2 at Visit 1A (as calculated using the abbreviated Modification of Diet in Renal Disease \[MDRD\] equation.
Any prior course of at least 1 month of treatment with ≥1 of an immunosuppressant therapy(ies) for iMN:
Subjects must be followed for at least 3 months after treatment prior to screening with the exception of rituximab or a cytotoxic based therapy, where the follow-up period is 6 months after treatment. If after follow-up it was determined that the subject did not achieve a complete or partial remission or suffered a relapse after achieving a partial remission, the subject will be eligible for the study.
If in the investigator's opinion, the subject should be enrolled prior to meeting the follow-up period criteria and the decrease in proteinuria is no longer occurring, discussion between the investigator and the Medical Monitor must take place for approval to enter screening.
History of treatment-resistant iMN defined as either having had no remission or having suffered a relapse after achieving a partial remission to their most recent standard treatment regimen as defined in the Definition of Response Status Table despite treatment with at least 1 month of treatment with a prior therapy for iMN. Note the following:
a. If the subject has been treated with prior standard therapy and can no longer be re-treated with any component of that therapy, regardless of whether a complete or partial remission was achieved, then the subject may be eligible, but approval from the Medical Monitor is required.
i. For example, if early discontinuation of standard therapy occurred because of a serious adverse event (Grade 3 or 4) during the treatment, regardless of whether a partial or complete remission was achieved, then the subject may be eligible.
b. If (a) does not apply, and the subject did not have either a partial or complete remission to the most recent treatment regimen, then the subject is eligible.
+26 more criteria

Contact the study team to confirm eligibility.