Steroid Treatment for Kidney Disease

This study has been completed.

Study NCT00065611 Information provided by National Institutes of Health Clinical Center (CC)

First Received on July 28, 2003. Last Updated on September 20, 2011 History of Changes

Results First Received: September 20, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Nephrosis Focal Lipoid Glomerulosclerosis
Intervention:	Drug: Oral dexamethasone

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
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
2 Doses Every 2 Weeks Arm	Patients in this arm receive 2 doses every 2 weeks
4 Doses Every 4 Weeks Arm	Patients in this arm receive 4 doses every 4 weeks

Participant Flow: Overall Study

	2 Doses Every 2 Weeks Arm	4 Doses Every 4 Weeks Arm
STARTED	4	4
COMPLETED	4	3
NOT COMPLETED	0	1

Baseline Characteristics

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Reporting Groups

	Description
2 Doses Every 2 Weeks Arm	Patients in this arm receive 2 doses every 2 weeks
4 Doses Every 4 Weeks Arm	Patients in this arm receive 4 doses every 4 weeks

Baseline Measures

	2 Doses Every 2 Weeks Arm	4 Doses Every 4 Weeks Arm	Total
Number of Participants [units: participants]	4	3	7
Age [units: years] Mean ± Standard Deviation	38 ± 9	30 ± 5	35 ± 8
Gender [units: participants]
Female	2	2	4
Male	2	1	3
Race/Ethnicity, Customized [units: participants]
White	1	1	2
African American	2	2	4
Asian	1	0	1
Region of Enrollment [units: participants]
United States	4	3	7
Urine Protein [units: g/d] Mean ± Standard Deviation	11.2 ± 7.0	10.0 ± 1.9	10.8 ± 5.1
CKD-EPI eGFR ^[1] [units: ml/min/1.73m^2] Mean ± Standard Deviation	59.2 ± 13.4	76.3 ± 21.4	66.6 ± 18.1

[1]	estimate glomerular filtration rate (GFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula

Outcome Measures

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1. Primary:

Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks [ Time Frame: 48 weeks from baseline ]

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2. Secondary:

Urine Protein [ Time Frame: 48 weeks from baseline ]

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3. Secondary:

CKD-EPI eGFR [ Time Frame: 48 weeks from baseline ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
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Results Point of Contact:

Name/Title: Jeffrey B Kopp, MD
Organization: NIDDK, NIH
phone: 3015943403
e-mail: jbkopp@nih.gov

Publications:

Adhikari M, Bhimma R, Coovadia HM. Intensive pulse therapies for focal glomerulosclerosis in South African children. Pediatr Nephrol. 1997 Aug;11(4):423-8.

Yorgin PD, Krasher J, Al-Uzri AY. Pulse methylprednisolone treatment of idiopathic steroid-resistant nephrotic syndrome. Pediatr Nephrol. 2001 Mar;16(3):245-50.

Houser MT, Jahn MF, Kobayashi A, Walburn J. Assessment of urinary protein excretion in the adolescent: effect of body position and exercise. J Pediatr. 1986 Sep;109(3):556-61.

Responsible Party:	National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:	NCT00065611 History of Changes
Other Study ID Numbers:	030226, 03-DK-0226
Study First Received:	July 28, 2003
Results First Received:	September 20, 2011
Last Updated:	September 20, 2011
Health Authority:	United States: Federal Government