Overview

Sulodexide Treatment in Patients With Dense Deposit Disease

Status:
Withdrawn

Trial end date:
2009-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Iowa

Treatments:

Glucuronyl glucosamine glycan sulfate

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 -