Acthar as Rescue Therapy for Transplant Glomerulopathy in... | NCT02057523

NCT02057523

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Mallinckrodt	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Acthar	Experimental	Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.	Drug: Acthar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acthar	Drug	Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.

Outcomes Module

Measure	Description	Time Frame
50% Reduction in Proteinuria or Proteinuria < 150mg/Day		6 months

Measure	Description	Time Frame
25% Improvement in the MDRD eGFR		6 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Sanjeev Akkina, MD	University of Illinois at Chicago	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinois at Chicago		Chicago	Illinois	60612	United States

Arm/Group Information

ID	Title	Description
FG000	Acthar	Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Acthar	Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

50% Reduction in Proteinuria or Proteinuria < 150mg/Day

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Acthar	Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.

Units

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Acthar	Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. Acthar: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Sanjeev Akkina	Loyola University Medical Center	7082166389		sanjeev.akkina@lumc.edu

Condition Browse Module

ID	Term
D011507	Proteinuria

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Intervention Browse Module

ID	Term
D053486	Melanocortins
D011333	Pro-Opiomelanocortin
D007028	Hypothalamic Hormones
D036361	Peptide Hormones