Sulodexide Treatment in Patients With Dense Deposit Disease
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ClinicalTrials.gov Identifier: NCT00583427 |
Recruitment Status :
Withdrawn
(This study put on inactive status due to no identifiable subjects to enter the protocol.)
First Posted : December 31, 2007
Last Update Posted : June 11, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dense Deposit Disease | Drug: Sulodexide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Sulodexide |
Drug: Sulodexide
200 mg per day in an oral gelcap form
Other Name: KRX-101 (sulodexide) |
- To see if Sulodexide will prevent or slow down the progression of DDD [ Time Frame: 6 mo. ]
- Normalization of complement function [ Time Frame: 1 year ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583427
United States, Iowa | |
Richard Smith, MD | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Richard JH Smith, MD | University of Iowa |
Responsible Party: | Richard JH Smith, MD, University of Iowa |
ClinicalTrials.gov Identifier: | NCT00583427 |
Other Study ID Numbers: |
200704758 |
First Posted: | December 31, 2007 Key Record Dates |
Last Update Posted: | June 11, 2015 |
Last Verified: | June 2015 |
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 |