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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02633046




Registration number
NCT02633046
Ethics application status
Date submitted
15/12/2015
Date registered
17/12/2015

Titles & IDs
Public title
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
Scientific title
Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A Prospective Study of Acthar (PODOCYTE)
Secondary ID [1] 0 0
MNK14224049
Universal Trial Number (UTN)
Trial acronym
PODOCYTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Focal Segmental Glomerulosclerosis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Acthar Gel

Other: Acthar Gel - Acthar Gel, 1 mL (80 U) by subcutaneous injection (SC) 3x/week will be administered to all participants from Week 0 to 50. Tapering of dose to 1 mL SC 2x/week will be allowed for safety and/ tolerability issues. Once the dose is tapered to 1 mL SC 2x/week it must remain at this level. Participants unable to tolerate 1 mL SC 2x/week will be discontinued. All participants will have an End of Study/Early Termination Visit 4 weeks after discontinuing Investigational Medicinal Product (IMP).


Treatment: Drugs: Acthar Gel
Acthar Gel 80 U/mL solution for subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
within 56 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria

Potential participants must meet the following summary criteria for inclusion in the study:

* Is male or non-pregnant, non-lactating female
* Has primary FSGS, is nephrotic and did not achieve at least partial proteinuria response with prior therapy
* Has been treated with an angiotensin converting enzyme inhibitor or receptor blocker (or have documented intolerance), for at least 4 weeks before screening
* Has blood pressure no higher than 150/90 mmHg
* Meets all other inclusion criteria detailed in the protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Potential participants will not be eligible for the the study if they meet the following summary criteria:

* Has hepatitis B or C, tuberculosis, or other contraindication listed on the United States (US) Prescribing Information for Acthar
* Has Type 1 or Type 2 diabetes mellitus or any clinically significant infection
* Has received specific treatments at exclusionary time points per protocol
* Has been involved in a therapeutic drug/device trial (other than for FSGS) within 4 weeks before screening
* Meets any other exclusion criteria detailed in the protocol
* Has any other condition that might, per protocol or in the opinion of the investigator, compromise:

1. the safety and well-being of the participant or their offspring
2. the safety of study staff
3. analysis of results

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/08/2020
Sample size
Target
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Renal Research Group - Gosford
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Westmead Hospita - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Launceston Hospital - Launceston
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Sunshine Hopital - Western Health - St Albans
Recruitment postcode(s) [1] 0 0
3021 - Gosford
Recruitment postcode(s) [2] 0 0
3021 - Liverpool
Recruitment postcode(s) [3] 0 0
3021 - Westmead
Recruitment postcode(s) [4] 0 0
3021 - Herston
Recruitment postcode(s) [5] 0 0
3021 - Launceston
Recruitment postcode(s) [6] 0 0
3021 - Melbourne
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Argentina
State/province [16] 0 0
BA
Country [17] 0 0
Argentina
State/province [17] 0 0
Córdoba
Country [18] 0 0
Chile
State/province [18] 0 0
IX Region
Country [19] 0 0
Chile
State/province [19] 0 0
RM
Country [20] 0 0
Mexico
State/province [20] 0 0
Morelos
Country [21] 0 0
Mexico
State/province [21] 0 0
Nuevo Leon
Country [22] 0 0
Peru
State/province [22] 0 0
Lima
Country [23] 0 0
Peru
State/province [23] 0 0
Lima Lima
Country [24] 0 0
Turkey
State/province [24] 0 0
Sisli
Country [25] 0 0
Turkey
State/province [25] 0 0
Topkapi
Country [26] 0 0
Turkey
State/province [26] 0 0
Ankara
Country [27] 0 0
Turkey
State/province [27] 0 0
Istanbul
Country [28] 0 0
Turkey
State/province [28] 0 0
Kocaeli
Country [29] 0 0
Turkey
State/province [29] 0 0
Maltepe
Country [30] 0 0
Turkey
State/province [30] 0 0
Mersin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mallinckrodt ARD LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Team Leader
Address 0 0
Mallinckrodt
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT02633046) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at [email protected].


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02633046