Sulodexide Treatment in Patients With Dense Deposit Disease

Study Overview
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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.

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.

Official Title
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Sulodexide Treatment in Patients With Dense Deposit Disease

Conditions
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Dense Deposit Disease

Intervention / Treatment
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* Drug: Sulodexide


Participation Criteria
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Eligibility Criteria
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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 Inability to give an informed consent or cooperate with the study personnel -

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sulodexide<br> | Drug: Sulodexide<br>* 200 mg per day in an oral gelcap form<br>* Other names: KRX-101 (sulodexide);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To see if Sulodexide will prevent or slow down the progression of DDD |  | 6 mo. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of complement function |  | 1 year |