Sulodexide Treatment in Patients With Dense Deposit Disease
The purpose of this study is to see if a medicine called Sulodexide will help prevent or slow down the progression of Membranoproliferative Glomerulonephritis type II/Dense Deposit Disease. Sulodexide is not yet FDA approved and has not been studied in children.
Study aim/hypotheses: to measure the efficacy of Sulodexide treatment in patients with the above disease/s.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Sulodexide Treatment in Patients With Dense Deposit Disease|
- To see if Sulodexide will prevent or slow down the progression of DDD [ Time Frame: 6 mo. ] [ Designated as safety issue: No ]
- Normalization of complement function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
200 mg per day in an oral gelcap form
Other Name: KRX-101 (sulodexide)
Study subjects will be asked to take Sulodexide twice a day. The Sulodexide will be taken in addition to the regular medications the subject is on. There will be no change in these other medications. The subject will also be asked to have blood tests each month to follow kidney function. The frequency of these tests is the normal/standard frequency for persons with MPGN II/DDD and is neither increased nor decreased because of participation in this study. The study will occur over 6 months for each subject.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583427
|United States, Iowa|
|Richard Smith, MD|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Richard JH Smith, MD||University of Iowa|