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Trial record 73 of 163 for:    ISOTRETINOIN

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
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Isotretinoin
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 12
Started Isotretinoin 8
Completed 6
Not Completed 6
Reason Not Completed
Adverse Event             2
Lost to Follow-up             1
elevated liver enzymes             1
Low urine PCR             1
Low epidermal growth factor receptor             1
Arm/Group Title Isotretinoin
Hide Arm/Group Description subjects will be treated with iIsotretinoin.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
48  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 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  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants
626.42  (642.58)
Creatinine, Urine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants
71.37  (43.36)
Protein/Creatinine Ratio, Urine  
Mean (Standard Deviation)
Unit of measure:  G/g
Number Analyzed 12 participants
8.42  (4.69)
1.Primary Outcome
Title Change in Proteinuria at Week 24 From Baseline
Hide Description Change of proteinuria at Week 24 compared to the baseline using protein/creatinine ratio (PCR)
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 7 patients is analyzed due to 1 withdrawal.
Arm/Group Title Isotretinoin
Hide Arm/Group Description:
oral isotretinoin
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: g/g
Baseline 8.42  (4.69)
Week 24 7.67  (5.36)
2.Secondary Outcome
Title Number of Patients Who Are in Complete Remission (CR) or Partial Remission (PR) at 6 Months or at the End of One Year.
Hide Description Based on 24hour proteinuria, response outcomes are defined as CR (complete remission): <0.3 g/g PR (partial remission): 50% fall from baseline and <2.0 g/g
Time Frame End of one year from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Seven out of 8 subjects who were treated with isotretinoin completed Week 24. One out of the 7 subjected who completed Week 24 did not complete the whole study.
Arm/Group Title Isotretinoin
Hide Arm/Group Description:
oral isotretinoin
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Isotretinoin
Hide Arm/Group Description Subjects will be treated with isotretinoin .
All-Cause Mortality
Isotretinoin
Affected / at Risk (%)
Total   0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Isotretinoin
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Isotretinoin
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Alopecia *  1/8 (12.50%)  1
Anemia *  2/8 (25.00%)  3
Ascites *  1/8 (12.50%)  1
Edema Limbs *  3/8 (37.50%)  4
Edema Trunk *  1/8 (12.50%)  1
Epistaxis *  1/8 (12.50%)  1
Periorbital edema *  1/8 (12.50%)  2
Cardiac disorders   
Hypertension *  3/8 (37.50%)  3
Pacemaker placed *  1/8 (12.50%)  1
Vasovagal reaction *  1/8 (12.50%)  1
Eye disorders   
Dry eye *  1/8 (12.50%)  1
Night Blindness *  1/8 (12.50%)  1
Gastrointestinal disorders   
Anorexia *  2/8 (25.00%)  2
Dyspepsia *  2/8 (25.00%)  2
Hemorrhoidal hemorrhage *  1/8 (12.50%)  2
Nausea *  1/8 (12.50%)  1
General disorders   
Conduction disorder *  1/8 (12.50%)  1
Dexamethasone x4 doses: start MMF and CSA *  1/8 (12.50%)  1
Fatigue *  4/8 (50.00%)  4
Headache *  1/8 (12.50%)  1
Hoarseness *  1/8 (12.50%)  1
Scalp pain *  2/8 (25.00%)  2
Watering eyes *  1/8 (12.50%)  1
Hepatobiliary disorders   
Aspartate aminotransferase increased *  1/8 (12.50%)  1
Cholesterol high *  1/8 (12.50%)  1
Immune system disorders   
Arthralgia (knee/ankle) *  1/8 (12.50%)  1
Infections and infestations   
Postnasal drip *  1/8 (12.50%)  1
Productive cough *  2/8 (25.00%)  2
Metabolism and nutrition disorders   
Metabolism and nutrition disorders *  1/8 (12.50%)  1
Weight loss *  1/8 (12.50%)  1
Nervous system disorders   
Agitation *  1/8 (12.50%)  3
Facial pain *  1/8 (12.50%)  1
Renal and urinary disorders   
Alanine aminotransferase increased *  1/8 (12.50%)  1
Creatinine Increased CTCAE *  1/8 (12.50%)  1
Creatinine increased *  1/8 (12.50%)  2
Hyperkalemia *  2/8 (25.00%)  6
Reproductive system and breast disorders   
Vaginal hemorrhage *  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Wheezing *  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Dry skin *  1/8 (12.50%)  2
Dry skin (lips) *  2/8 (25.00%)  4
Pruritis *  1/8 (12.50%)  3
Rash maculo-papular *  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders *  1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Jeffery Kopp
Organization: National Institutes of Diabetes, Digestive, and Kidney Disorders
Phone: 301-594-3403
EMail: koppj@mail.nih.gov
Layout table for additonal information
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