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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

December 20, 2007
January 14, 2010
December 2007
December 2009   (final data collection date for primary outcome measure)
To see if Sulodexide will prevent or slow down the progression of DDD [ Time Frame: 6 mo. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00583427 on ClinicalTrials.gov Archive Site
Normalization of complement function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sulodexide Treatment in Patients With Dense Deposit Disease
Sulodexide Treatment in Patients With Dense Deposit Disease

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Dense Deposit Disease
Drug: Sulodexide
200 mg per day in an oral gelcap form
Other Name: KRX-101 (sulodexide)
Experimental: Sulodexide
Intervention: Drug: Sulodexide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
December 2009
December 2009   (final data collection date for primary outcome measure)

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 -
Both
5 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00583427
200704758
Yes
Richard JH Smith, MD, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Richard JH Smith, MD University of Iowa
University of Iowa
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP