Back to resultsSulodexide Treatment in Patients With Dense Deposit Disease
Primary Purpose
Dense Deposit Disease
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sulodexide
Sponsored by
About this trial
This is an interventional prevention trial for Dense Deposit Disease
Eligibility 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 -
Sites / Locations
- Richard Smith, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sulodexide
Arm Description
Outcomes
Primary Outcome Measures
To see if Sulodexide will prevent or slow down the progression of DDD
Secondary Outcome Measures
Normalization of complement function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00583427
Brief Title
Sulodexide Treatment in Patients With Dense Deposit Disease
Official Title
Sulodexide Treatment in Patients With Dense Deposit Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
This study put on inactive status due to no identifiable subjects to enter the protocol.
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Iowa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dense Deposit Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sulodexide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sulodexide
Other Intervention Name(s)
KRX-101 (sulodexide)
Intervention Description
200 mg per day in an oral gelcap form
Primary Outcome Measure Information:
Title
To see if Sulodexide will prevent or slow down the progression of DDD
Time Frame
6 mo.
Secondary Outcome Measure Information:
Title
Normalization of complement function
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard JH Smith, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard Smith, MD
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sulodexide Treatment in Patients With Dense Deposit Disease
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