Sulodexide Treatment in Patients With Dense Deposit Disease

Dense Deposit Disease Clinical Trial

Official title:

Sulodexide Treatment in Patients With Dense Deposit Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00583427
• Other study ID #: 200704758
• Status: Withdrawn
• Phase: Phase 1
• First received: December 20, 2007
• Last updated: June 10, 2015
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2015
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 20 Years

Eligibility

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 -

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dense Deposit Disease
• Glomerulonephritis, Membranoproliferative

Intervention

Drug:
• Sulodexide
200 mg per day in an oral gelcap form

Locations

Country	Name	City	State
United States	Richard Smith, MD	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To see if Sulodexide will prevent or slow down the progression of DDD		6 mo.	No
Secondary	Normalization of complement function		1 year	No