Text Size

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:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00583427
First received: December 20, 2007
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  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:

U.S. FDA Resources

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:

  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 2) also known as Dense Deposit Disease
  3. Evidence of hepatic dysfunction including total bilirubin >2.0mg/dL (34 micromol/L) or liver enzymes >3 times upper limit of normal.
  4. 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
  5. any risk of bleeding, including a history of bleeding diathesis and a platelet count <100,000/mm3
  6. active cancer
  7. 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.
  8. Known allergy or intolerance to any heparin-like compounds
  9. Inability to give an informed consent or cooperate with the study personnel -
  Contacts and Locations
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
Nephritis
Kidney Diseases
Urologic Diseases
Immune System Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013