Sulodexide Treatment in Patients With Dense Deposit Disease

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Dense Deposit Disease	Drug: Sulodexide	Phase 1

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Intervention Model:	Single Group Assignment
Masking:	Single (Participant)
Primary Purpose:	Prevention
Official Title:	Sulodexide Treatment in Patients With Dense Deposit Disease
Study Start Date :	December 2007
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	December 2009

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Sulodexide	Drug: Sulodexide; 200 mg per day in an oral gelcap form; Other Name: KRX-101 (sulodexide)

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Normalization of complement function [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 20 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 -

Contacts and Locations

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Locations

United States, Iowa
Richard Smith, MD
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

Investigators

Principal Investigator:	Richard JH Smith, MD	University of Iowa

More Information

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Responsible Party:	Richard JH Smith, MD, University of Iowa
ClinicalTrials.gov Identifier:	NCT00583427 History of Changes
Other Study ID Numbers:	200704758
First Posted:	December 31, 2007
Last Update Posted:	June 11, 2015
Last Verified:	June 2015

Additional relevant MeSH terms:

Glomerulonephritis, Membranoproliferative; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Immune System Diseases; Glucuronyl glucosamine glycan sulfate; Anticoagulants	Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Hypoglycemic Agents; Physiological Effects of Drugs