NCT00130312

Brief Summary

The purpose of this study is to determine whether sulodexide is effective in slowing or preventing the progression of diabetic kidney disease.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
968

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

Typical duration for phase_4

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

2.6 years

First QC Date

August 11, 2005

Last Update Submit

March 17, 2021

Conditions

Diabetic Nephropathy

Keywords

DiabetesDiabetic NephropathyProteinuria

Outcome Measures

Primary Outcomes (2)

  • Time to doubling of the serum creatinine or end stage kidney disease (ESRD)

    Time in study depended on time to doubling of serum creatinine and when the patient was enrolled in the trial.

    Time in study depended on time to doubling of serum creatinine

  • Safety and tolerance of sulodexide therapy long-term

    Review of laboratory parameters, adverse events, physical examinations, etc. were made to evaluate patient safety.

    Time in study depended on time to doubling of serum creatinine

Secondary Outcomes (1)

  • Change in urinary protein/albumin excretion

    Time in study depended on time to doubling of serum creatinine

Study Arms (2)

Sulodexide

EXPERIMENTAL

Also known as KRX-101. These patients are also on ACEs and ARBs (irbesartin and/or losartan).

Drug: Sulodexide

Placebo

PLACEBO COMPARATOR

These patients are also on ACEs and ARBs (irbesartin and/or losartan).

Drug: Placebo

Interventions

SulodexideDRUG

100 mg gelcap in the morning and evening

Also known as: KRX-101
Sulodexide
PlaceboDRUG

1 placebo gelcap in the morning and evening

Also known as: placebo gelpcap
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes;
  • Urine protein to creatinine ratio (PCR) equal to or greater than 900 mg/G (101.7 mg/mmol) in women and equal to or greater than 650 mg/G (73.45 mg/mmol) in men;
  • Serum creatinine in women 1.3 - 3.0 mg/dL (115-265 μmol/L), inclusive, and in men 1.5 - 3.0 mg/dL (133-265 μmol/L), inclusive;
  • Willing to discontinue antihypertensive medication regimen, if applicable;
  • Willing and able to give informed consent.

You may not qualify if:

  • Type 1 (insulin-dependent; juvenile onset) diabetes;
  • Renal disease as follows:
  • Patients with known non-diabetic renal disease (nephrosclerosis superimposed on diabetic nephropathy acceptable), or
  • Renal allograft;
  • Absolute requirement for combination therapy of angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB);
  • Patients who require ACEI, but not ACEI/ARB combination;
  • Cardiovascular disease as follows:
  • Unstable angina pectoris within 3 months of study entry;
  • Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study entry;
  • Transient ischemic attack within 3 months of study entry;
  • Cerebrovascular accident within 3 months of study entry;
  • New York Heart Association Functional Class III or IV (Note: if a patient is New York Heart Association Functional Class I or II and requires an ACEI, consult with the Clinical Coordinating Center to obtain permission for the patient to be on an ACEI rather than an ARB);
  • Obstructive valvular heart disease or hypertrophic cardiomyopathy; or
  • Second or third degree atrioventricular block not successfully treated with a pacemaker;
  • Need for chronic (\>2 weeks) immunosuppressive therapy, including corticosteroids (excluding inhaled or nasal steroids);
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Collaborative Study Group, Clinical Coordinating Center for U.S. and Canadian clinics, Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The Collaborative Study Group, Clinical Coordinating Center for the Pacific Region, Monash Medical Center

Melbourne, Victoria, 3168, Australia

Location

The Collaborative Study Group, Clinical Coordinating Center for European Clinics, University of Groningen

Groningen, 9713 AV, Netherlands

Location

Related Publications (1)

  • Bidadkosh A, Lambooy SPH, Heerspink HJ, Pena MJ, Henning RH, Buikema H, Deelman LE. Predictive Properties of Biomarkers GDF-15, NTproBNP, and hs-TnT for Morbidity and Mortality in Patients With Type 2 Diabetes With Nephropathy. Diabetes Care. 2017 Jun;40(6):784-792. doi: 10.2337/dc16-2175. Epub 2017 Mar 24.

    PMID: 28341782DERIVED

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes MellitusProteinuria

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edmund J Lewis, MD

    The Collaborative Study Group, Rush University Medical Center, Chicago, IL USA

    STUDY DIRECTOR

  • Robert C Atkins, M.D.

    The Collaborative Study Group, Monash Medical Center, Clayton, Victoria, AUSTRALIA

    PRINCIPAL INVESTIGATOR

  • Dick deZeeuw, M.D.

    The Collaborative Study Group, University of Groningen, NETHERLANDS

    PRINCIPAL INVESTIGATOR

  • Itamar Raz, M.D.

    The Collaborative Study Group, Hadassah University, Jerusalem, ISRAEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 15, 2005

Study Start

August 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)AU(1)US(1)