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Sulodexide Treatment in Patients With Dense Deposit Disease

Sponsor
University of Iowa (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00583427
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
24
Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
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 :
Dec 1, 2007
Anticipated Primary Completion Date :
Dec 1, 2009
Anticipated Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sulodexide

Drug: Sulodexide
200 mg per day in an oral gelcap form
Other Names:
  • KRX-101 (sulodexide)

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Normalization of complement function [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. also known as Dense Deposit Disease

    1. Evidence of hepatic dysfunction including total bilirubin >2.0mg/dL (34 micromol/L) or liver enzymes >3 times upper limit of normal.

    2. 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

    3. any risk of bleeding, including a history of bleeding diathesis and a platelet count <100,000/mm3

    4. active cancer

    5. 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.

    6. Known allergy or intolerance to any heparin-like compounds

    7. Inability to give an informed consent or cooperate with the study personnel -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00583427
    Other Study ID Numbers:
    • 200704758
    First Posted:
    Dec 31, 2007
    Last Update Posted:
    Jun 11, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Glomerulonephritis, Membranoproliferative
    Glucuronyl glucosamine glycan sulfate

    Study Results

    No Results Posted as of Jun 11, 2015