Sulodexide Treatment in Patients With Dense Deposit Disease

NCT00583427 | Withdrawn Phase 1 DMC

• 1 other identifier: 200704758
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dense Deposit Disease

Outcome Measures

Primary Outcomes (1)

• To see if Sulodexide will prevent or slow down the progression of DDD

  6 mo.

Secondary Outcomes (1)

• Normalization of complement function

  1 year

Study Arms (1)

Sulodexide

EXPERIMENTAL

Drug: Sulodexide

Interventions

Sulodexide DRUG

200 mg per day in an oral gelcap form

Also known as: KRX-101 (sulodexide)

Sulodexide

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must be 5 yrs. to 20 yrs. old
• Patients must have Membranoproliferative Glomerulonephritis Type II (MPGN2), also known as Dense Deposit Disease (DDD)

You may not qualify if:

• Patients less than 5 years of age or older than 20 years of age
• Patients who DO NOT have a diagnosis of Membranoproliferative Glomerulonephritis (MPGN 2) also known as Dense Deposit Disease
• Evidence of hepatic dysfunction including total bilirubin \>2.0mg/dL (34 micromol/L) or liver enzymes \>3 times upper limit of normal.
• 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
• any risk of bleeding, including a history of bleeding diathesis and a platelet count \<100,000/mm3
• active cancer
• 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.
• Known allergy or intolerance to any heparin-like compounds
• Inability to give an informed consent or cooperate with the study personnel -

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

Richard Smith, MD

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Glomerulonephritis, Membranoproliferative

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Immune System Diseases

Study Officials

• Richard JH Smith, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

US (1)