Sulodexide Treatment in Patients With Dense Deposit Disease | NCT00583427

Studies
Sulodexide Treatment in Patients With Dense Deposit Disease

NCT00583427

Sponsor

University of Iowa

Status

Withdrawn

Last Update Posted

Jun 11, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Dense Deposit Disease

Interventions

Sulodexide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study put on inactive status due to no identifiable subjects to enter the protocol.

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 28, 2007

First Posted Date

Dec 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2015

Last Update Posted Date

Jun 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Sulodexide	Experimental		Drug: Sulodexide

Name	Type	Description	Arm Group Labels	Other Names
Sulodexide	Drug	200 mg per day in an oral gelcap form	Sulodexide	KRX-101 (sulodexide)

Measure	Description	Time Frame
To see if Sulodexide will prevent or slow down the progression of DDD		6 mo.

Measure	Description	Time Frame
Normalization of complement function		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases