Sulodexide Treatment in Patients With Dense Deposit Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT00583427
• Date of registration: 20/12/2007
• Prospective Registration: No
• Primary sponsor: University of Iowa
• Public title: Sulodexide Treatment in Patients With Dense Deposit Disease
• Scientific title: Sulodexide Treatment in Patients With Dense Deposit Disease
• Date of first enrolment: December 2007
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00583427
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Richard JH Smith, MD
• Affiliation: University of Iowa

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients must be 5 yrs. to 20 yrs. old

2. Patients must have Membranoproliferative Glomerulonephritis Type II (MPGN2), also
known as Dense Deposit Disease (DDD)

Exclusion Criteria:

1. Patients less than 5 years of age or older than 20 years of age

2. Patients who DO NOT have a diagnosis of Membranoproliferative Glomerulonephritis
(MPGN 2) also known as Dense Deposit Disease

3. Evidence of hepatic dysfunction including total bilirubin >2.0mg/dL (34 micromol/L)
or liver enzymes >3 times upper limit of normal.

4. A history of any major medical condition (excluding DDD), including but not limited
to: gastrointestinal bleeding in the past 3 months; HIV; active Hepatitis B or C
(current active disease defined as an abnormal liver biopsy or persistent, elevated
transaminases, SGOT, SGPT); and other medical conditions deemed serious by the
investigator

5. any risk of bleeding, including a history of bleeding diathesis and a platelet count
<100,000/mm3

6. active cancer

7. Participation in any experimental drug study in the 60 days prior to entry into this
study; or plan to participate in any experimental drug study during the study period.

8. Known allergy or intolerance to any heparin-like compounds

9. Inability to give an informed consent or cooperate with the study personnel -



Age minimum: 5 Years
Age maximum: 20 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dense Deposit Disease

Intervention(s)

Drug: Sulodexide

Primary Outcome(s)

To see if Sulodexide will prevent or slow down the progression of DDD [Time Frame: 6 mo.]

Secondary Outcome(s)

Normalization of complement function [Time Frame: 1 year]

Secondary ID(s)

200704758

Source(s) of Monetary Support

Please refer to primary and secondary sponsors