WithdrawnPhase 1

Sulodexide Treatment in Patients With Dense Deposit Disease

Stopped: This study put on inactive status due to no identifiable subjects to enter the protocol.

United States0Started 2007-12

Plain-language 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.

Who can participate

Age range5 Years – 20 Years

SexALL

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Inclusion criteria

✓. Patients must be 5 yrs. to 20 yrs. old
✓. Patients must have Membranoproliferative Glomerulonephritis Type II (MPGN2), also known as Dense Deposit Disease (DDD)

Exclusion criteria

✕. Patients less than 5 years of age or older than 20 years of age
✕. Patients who DO NOT have a diagnosis of Membranoproliferative Glomerulonephritis (MPGN 2) also known as Dense Deposit Disease
✕. Evidence of hepatic dysfunction including total bilirubin \>2.0mg/dL (34 micromol/L) or liver enzymes \>3 times upper limit of normal.
✕. 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
✕. any risk of bleeding, including a history of bleeding diathesis and a platelet count \<100,000/mm3
✕. active cancer
✕. 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.
✕. Known allergy or intolerance to any heparin-like compounds

What they're measuring

To see if Sulodexide will prevent or slow down the progression of DDD

Timeframe: 6 mo.

Trial details

NCT IDNCT00583427

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

View on ClinicalTrials.gov More Dense Deposit Disease trials