Sulodexide Treatment in Patients With Dense Deposit Disease
This study has been terminated.
(This study put on inactive status due to no identifiable subjects to enter the protocol.)
Sponsor:
University of Iowa
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00583427
First received: December 20, 2007
Last updated: January 14, 2010
Last verified: January 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Dense Deposit Disease |
Drug: Sulodexide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Sulodexide Treatment in Patients With Dense Deposit Disease |
Resource links provided by NLM:
Further study details as provided by University of Iowa:
Primary Outcome Measures:
- To see if Sulodexide will prevent or slow down the progression of DDD [ Time Frame: 6 mo. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Normalization of complement function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sulodexide |
Drug: Sulodexide
200 mg per day in an oral gelcap form
Other Name: KRX-101 (sulodexide)
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 -
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583427
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583427
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
No publications provided
| Responsible Party: | Richard JH Smith, MD, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00583427 History of Changes |
| Other Study ID Numbers: | 200704758 |
| Study First Received: | December 20, 2007 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glomerulonephritis, Membranoproliferative Glomerulonephritis Immune System Diseases Kidney Diseases Nephritis Urologic Diseases Glucuronyl glucosamine glycan sulfate Anticoagulants Antimetabolites Cardiovascular Agents |
Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Hypoglycemic Agents Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015