Trial record 4 of 6 for:
"membranoproliferative glomerulonephritis type II" OR "Glomerulonephritis, Membranoproliferative"
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.)
Information provided by:
University of Iowa
First received: December 20, 2007
Last updated: January 14, 2010
Last verified: January 2010
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.
Dense Deposit Disease
||Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
||Sulodexide Treatment in Patients With Dense Deposit Disease
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
200 mg per day in an oral gelcap form
Other Name: KRX-101 (sulodexide)
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.
|Ages Eligible for Study:
||5 Years to 20 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must be 5 yrs. to 20 yrs. old
- Patients must have Membranoproliferative Glomerulonephritis Type II (MPGN2), also known as Dense Deposit Disease (DDD)
- 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 -
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
|Richard Smith, MD
|Iowa City, Iowa, United States, 52242 |
University of Iowa
||Richard JH Smith, MD
||University of Iowa
No publications provided
||Richard JH Smith, MD, University of Iowa
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 20, 2007
||January 14, 2010
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Immune System Diseases
Glucuronyl glucosamine glycan sulfate
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrin Modulating Agents
Physiological Effects of Drugs