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Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155141
First Posted: July 1, 2010
Last Update Posted: September 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Stanford University
Results First Submitted: August 1, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Kidney Diseases
Intervention: Drug: H.P. Acthar Gel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
H.P. Acthar Gel Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.

Participant Flow:   Overall Study
    H.P. Acthar Gel
STARTED   16 
COMPLETED   14 
NOT COMPLETED   2 
Withdrawal by Subject                1 
Screen Failure                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
H.P. Acthar Gel Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.

Baseline Measures
   H.P. Acthar Gel 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Median (Standard Deviation)
 40  (15.1) 
Gender 
[Units: Participants]
 
Female   6 
Male   9 
24 hour proteinuria 
[Units: G/day]
Median (Standard Deviation)
 3.6  (5.7) 
Serum Creatinine 
[Units: mg/dL]
Median (Standard Deviation)
 1.4  (0.9) 
Protein/creatinine ratio 
[Units: Unitless]
Median (Standard Deviation)
 3.1  (2.3) 
Glucose 
[Units: mg/dL]
Median (Standard Deviation)
 95  (8.4) 
Weight 
[Units: Kg]
Median (Standard Deviation)
 87.3  (24.3) 
Systolic blood pressure 
[Units: Mm Hg]
Median (Standard Deviation)
 128  (15.9) 
Diastolic blood pressure 
[Units: Mm Hg]
Median (Standard Deviation)
 82  (9.8) 
Total cholesterol 
[Units: mg/dL]
Median (Standard Deviation)
 236  (99.5) 
eGFR 
[Units: mL/min/1.73m^2]
Median (Standard Deviation)
 56  (34.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   24 Hour Proteinuria   [ Time Frame: Baseline - Month 6 ]

2.  Primary:   Serum Creatinine   [ Time Frame: Baseline - Month 6 ]

3.  Primary:   Protein/Creatinine Ratio   [ Time Frame: Baseline - Month 6 ]

4.  Secondary:   eGFR   [ Time Frame: Baseline - Month 6 ]

5.  Secondary:   Weight   [ Time Frame: Baseline - Month 6 ]

6.  Secondary:   Systolic Blood Pressure   [ Time Frame: Baseline - Month 6 ]

7.  Secondary:   Diastolic Blood Pressure   [ Time Frame: Baseline - Month 6 ]

8.  Secondary:   Glucose   [ Time Frame: Baseline - Month 6 ]

9.  Secondary:   Total Cholesterol   [ Time Frame: Baseline - Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: Dr. Richard Lafayette
Organization: Stanford University
phone: 650-498-6063
e-mail: czar@stanford.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01155141     History of Changes
Other Study ID Numbers: SU-08182009-3600
First Submitted: June 29, 2010
First Posted: July 1, 2010
Results First Submitted: August 1, 2014
Results First Posted: September 1, 2014
Last Update Posted: September 1, 2014