Sulodexide Treatment in Patients With Dense Deposit Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dense Deposit Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Sulodexide

Group Type EXPERIMENTAL

Sulodexide

Intervention Type DRUG

200 mg per day in an oral gelcap form

Interventions

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Sulodexide

200 mg per day in an oral gelcap form

Intervention Type DRUG

Other Intervention Names

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KRX-101 (sulodexide)

Eligibility Criteria

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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 -

Minimum Eligible Age

5 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No