Clinical trial NCT00583427: Sulodexide Treatment in Patients With Dense Deposit Disease
Official title: Sulodexide Treatment in Patients With Dense Deposit Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Dense Deposit Disease
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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 -

Primary outcomes:
measure: To see if Sulodexide will prevent or slow down the progression of DDD
timeFrame: 6 mo.
Secondary outcomes:
measure: Normalization of complement function
timeFrame: 1 year
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Richard Smith, MD
state: Iowa
Study officials:
affiliation: University of Iowa
name: Richard JH Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: