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Podocyte Retinoids

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ClinicalTrials.gov Identifier: NCT00098020
Recruitment Status : Completed
First Posted : December 2, 2004
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Collapsing Glomerulopathy
Glomerulosclerosis, Focal Segmental
Intervention: Drug: Isotretinoin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Isotretinoin

Subjects will be treated with isotretinoin initially at 1mg/kg for the first 4 weeks and then dose will escalate to a higher dose only if subjects have tolerated the lower dose.

In younger patients of 16 and 17 years of age, the dose will be started at 1 mg/kg and will remain at this dose without escalation.


Participant Flow:   Overall Study
    Isotretinoin
STARTED   12 
Started Isotretinoin   8 
COMPLETED   6 
NOT COMPLETED   6 
Adverse Event                2 
Lost to Follow-up                1 
elevated liver enzymes                1 
Low urine PCR                1 
Low epidermal growth factor receptor                1 



  Baseline Characteristics

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
Isotretinoin subjects will be treated with iIsotretinoin.

Baseline Measures
   Isotretinoin 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (12.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  41.7% 
Male      7  58.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2  16.7% 
White      9  75.0% 
More than one race      0   0.0% 
Unknown or Not Reported      1   8.3% 
Protein, Urine 
[Units: mg/dL]
Mean (Standard Deviation)
 626.42  (642.58) 
Creatinine, Urine 
[Units: mg/dL]
Mean (Standard Deviation)
 71.37  (43.36) 
Protein/Creatinine Ratio, Urine 
[Units: G/g]
Mean (Standard Deviation)
 8.42  (4.69) 


  Outcome Measures

1.  Primary:   Change in Proteinuria at Week 24 From Baseline   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Number of Patients Who Are in Complete Remission (CR) or Partial Remission (PR) at 6 Months or at the End of One Year.   [ Time Frame: End of one year from baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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. Jeffery Kopp
Organization: National Institutes of Diabetes, Digestive, and Kidney Disorders
phone: 301-594-3403
e-mail: koppj@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00098020     History of Changes
Other Study ID Numbers: 050015
05-DK-0015 ( Other Identifier: NIH )
First Submitted: December 1, 2004
First Posted: December 2, 2004
Results First Submitted: June 8, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017