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Steroid Treatment for Kidney Disease

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ClinicalTrials.gov Identifier: NCT00065611
Recruitment Status : Completed
First Posted : July 29, 2003
Results First Posted : October 28, 2011
Last Update Posted : October 28, 2011
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 Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Nephrosis
Focal Lipoid Glomerulosclerosis
Intervention Drug: Oral dexamethasone
Enrollment 8
Recruitment Details 8 patients were enrolled in the study, 4 of them are randomized to 2 dose every 2 week arm and 4 of them are randomized to 4 dose every 4 week arm.
Pre-assignment Details  
Arm/Group Title 2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm
Hide Arm/Group Description Patients in this arm receive 2 doses every 2 weeks Patients in this arm receive 4 doses every 4 weeks
Period Title: Overall Study
Started 4 4
Completed 4 3
Not Completed 0 1
Arm/Group Title 2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm Total
Hide Arm/Group Description Patients in this arm receive 2 doses every 2 weeks Patients in this arm receive 4 doses every 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
38  (9) 30  (5) 35  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
2
  50.0%
2
  66.7%
4
  57.1%
Male
2
  50.0%
1
  33.3%
3
  42.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
White 1 1 2
African American 2 2 4
Asian 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
Urine Protein  
Mean (Standard Deviation)
Unit of measure:  G/d
Number Analyzed 4 participants 3 participants 7 participants
11.2  (7.0) 10.0  (1.9) 10.8  (5.1)
CKD-EPI eGFR   [1] 
Mean (Standard Deviation)
Unit of measure:  Ml/min/1.73m^2
Number Analyzed 4 participants 3 participants 7 participants
59.2  (13.4) 76.3  (21.4) 66.6  (18.1)
[1]
Measure Description: estimate glomerular filtration rate (GFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula
1.Primary Outcome
Title Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks
Hide Description Complete remission is defined as proteinuria <0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria <3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as >60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response.
Time Frame 48 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title 2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm
Hide Arm/Group Description:
Patients in this arm receive 2 doses every 2 weeks
Patients in this arm receive 4 doses every 4 weeks
Overall Number of Participants Analyzed 4 3
Measure Type: Number
Unit of Measure: participants
Limited response 1 1
Non-response 2 1
Partial remission 1 1
Complete remission 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 Doses Every 2 Weeks Arm, 4 Doses Every 4 Weeks Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9074
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Urine Protein
Hide Description [Not Specified]
Time Frame 48 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm
Hide Arm/Group Description:
Patients in this arm receive 2 doses every 2 weeks
Patients in this arm receive 4 doses every 4 weeks
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: g/d
3.6  (0.7) 6.2  (4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 Doses Every 2 Weeks Arm, 4 Doses Every 4 Weeks Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4566
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title CKD-EPI eGFR
Hide Description Estimate glomerular filtration rate (eGFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.
Time Frame 48 weeks from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm
Hide Arm/Group Description:
Patients in this arm receive 2 doses every 2 weeks
Patients in this arm receive 4 doses every 4 weeks
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: ml/min/1.73m^2
60  (16) 73  (20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 Doses Every 2 Weeks Arm, 4 Doses Every 4 Weeks Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3792
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm
Hide Arm/Group Description Patients in this arm receive 2 doses every 2 weeks Patients in this arm receive 4 doses every 4 weeks
All-Cause Mortality
2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      2/4 (50.00%)    
Gastrointestinal disorders     
Acute appendicitis, increased intraocular pressure  0/4 (0.00%)  0 2/4 (50.00%)  2
Musculoskeletal and connective tissue disorders     
Tendon rupture  1/4 (25.00%)  1 0/4 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2 Doses Every 2 Weeks Arm 4 Doses Every 4 Weeks Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      1/4 (25.00%)    
Gastrointestinal disorders     
Impaired glucose tolerance  0/4 (0.00%)  0 1/4 (25.00%)  1
General disorders     
Headache  1/4 (25.00%)  1 0/4 (0.00%)  0
sleep disturbance  1/4 (25.00%)  1 1/4 (25.00%)  1
Mood swings  2/4 (50.00%)  2 1/4 (25.00%)  1
Change in appetite  0/4 (0.00%)  0 1/4 (25.00%)  1
Weight gain  0/4 (0.00%)  0 1/4 (25.00%)  1
Cushingoid appearance  0/4 (0.00%)  0 1/4 (25.00%)  1
Infections and infestations     
Infections  1/4 (25.00%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle pains  1/4 (25.00%)  1 0/4 (0.00%)  0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey B Kopp, MD
Organization: NIDDK, NIH
Phone: 3015943403
EMail: jbkopp@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: NCT00065611    
Other Study ID Numbers: 030226
03-DK-0226
First Submitted: July 28, 2003
First Posted: July 29, 2003
Results First Submitted: September 20, 2011
Results First Posted: October 28, 2011
Last Update Posted: October 28, 2011