Viewing Study NCT00583427


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Study NCT ID: NCT00583427
Status: WITHDRAWN
Last Update Posted: 2015-06-11
First Post: 2007-12-20
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Sulodexide Treatment in Patients With Dense Deposit Disease
Sponsor: University of Iowa
Organization:

Study Overview

Official Title: Sulodexide Treatment in Patients With Dense Deposit Disease
Status: WITHDRAWN
Status Verified Date: 2015-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: This study put on inactive status due to no identifiable subjects to enter the protocol.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
Detailed Description: 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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: