Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02057523
• Collaborator: Mallinckrodt (Industry)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.

Condition or Disease	Intervention/Treatment	Phase
Proteinuria; Transplant Glomerulopathy	Drug: Acthar	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Acthar Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.

Drug: 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.; Other Names: Repository Corticotropin Hormone Acthar Gel Adrenocorticotropic Hormone

Outcome Measures

Primary Outcome Measures

1. 50% Reduction in Proteinuria or Proteinuria < 150mg/Day [6 months]

Secondary Outcome Measures

1. 25% Improvement in the MDRD eGFR [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy.

• Failed standard therapy (>25% reduction in proteinuria) including maximum use of an ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression

Exclusion Criteria:

• Diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• University of Illinois at Chicago
• Mallinckrodt

Investigators

• Principal Investigator: Sanjeev Akkina, MD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanjeev Akkina, Assistant Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT02057523
• Other Study ID Numbers: 2013-0764
• First Posted: Feb 7, 2014
• Last Update Posted: Sep 4, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Proteinuria; Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin

Study Results

Participant Flow

Arm/Group Title	Acthar
Arm/Group Description	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.
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Acthar
Arm/Group Description	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.
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 100%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acthar
Arm/Group Description	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.
Measure Participants	1
Count of Participants [Participants]	1 50%

2. Secondary Outcome

Title	25% Improvement in the MDRD eGFR
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acthar
Arm/Group Description	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.
Measure Participants	1
Count of Participants [Participants]	1 50%

Adverse Events

Time Frame	1 year
Arm/Group Title	Acthar
Arm/Group Description	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.
All Cause Mortality
	Acthar
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Acthar
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Acthar
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.