NCT00130208

Brief Summary

The purpose of the study is to determine whether treatment with sulodexide is effective in reducing the level of urine albumin excretion in patients with early diabetic kidney disease expressed as microalbuminuria.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,056

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2005

Geographic Reach
3 countries

3 active sites

Status
completed

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
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

March 23, 2018

Completed
Last Updated

March 23, 2018

Status Verified

February 1, 2018

Enrollment Period

2.4 years

First QC Date

August 11, 2005

Results QC Date

January 23, 2018

Last Update Submit

February 22, 2018

Conditions

Diabetic Nephropathy

Keywords

DiabetesDiabetes Mellitus, Type 2AlbuminuriaDiabetic Nephropathy

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria

    The primary efficacy variable was the fraction of those patients in the ITT population with valid baseline and Week 26 ACRs in whom "therapeutic success" was achieved at Week 26 measured as a conversion of microalbuminuria to normoalbuminuria and at least a 25% reduction in ACR relative to baseline

    26 Weeks

  • Number of Subjects With Greater Than 50% Reduction in Microalbuminuria

    During the treatment period, KRX-101 is being compared to placebo to assess whether a 50% reduction in microalbuminuria has been achieved.

    26 Weeks

Secondary Outcomes (1)

  • Change in Serum Albumin From Baseline to End of 26 Weeks

    26 Weeks

Study Arms (2)

Sulodexide

EXPERIMENTAL

Also known as KRX-101. All patients will be on standard of care ACE or ARBs.

Drug: Sulodexide

Placebo

PLACEBO COMPARATOR

All patients will be on standard of care ACE or ARBs.

Drug: Placebo

Interventions

SulodexideDRUG

100 mg sulodexide gelcaps

Also known as: KRX-101
Sulodexide
PlaceboDRUG

0 mg gelcap

Also known as: Placebo oral gelcap
Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of type 2 diabetes
  • Serum creatinine equal to or less than 1.5 mg/dL
  • Microalbuminuria, defined by a urine albumin/creatinine ratio in men; 35- 200 mg albumin/G creatinine, in women; 45-200 mg albumin/G creatinine
  • Blood pressure controlled to less than 150/90 mmHg
  • Willing to change antihypertensive medication regimen if necessary

You may not qualify if:

  • Age of onset of type 2 diabetes \<18 years;
  • HbA1C \>10.0%;
  • Morbid obesity defined as a body mass index (BMI) \>= 45 kg/m2;
  • Type 1 (insulin-dependent; juvenile onset) diabetes;
  • Renal disease as follows:
  • Patients with known non-diabetic renal disease
  • Renal allograft
  • Absolute requirement for combination therapy of angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB);
  • 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 or stent placement within 3 months of study entry;
  • Transient ischemic attack within 3 months of study entry;
  • Cerebrovascular accident within 3 months of study entry;
  • Symptomatic heart failure requiring ACE inhibition;
  • New York Heart Association Functional Class III or IV heart failure;
  • +22 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)

  • Lewis EJ, Lewis JB, Greene T, Hunsicker LG, Berl T, Pohl MA, de Zeeuw D, Heerspink HL, Rohde RD, Atkins RC, Reutens AT, Packham DK, Raz I; Collaborative Study Group. Sulodexide for kidney protection in type 2 diabetes patients with microalbuminuria: a randomized controlled trial. Am J Kidney Dis. 2011 Nov;58(5):729-36. doi: 10.1053/j.ajkd.2011.06.020. Epub 2011 Aug 26.

    PMID: 21872376DERIVED

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes MellitusDiabetes Mellitus, Type 2Albuminuria

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 DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Information
Organization
Keryx Biopharmaceuticals
medicalinfo@keryx.com
1-844-44-KERYX

Study Officials

  • Edmund J Lewis, M.D.

    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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
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

January 1, 2008

Study Completion

February 1, 2008

Last Updated

March 23, 2018

Results First Posted

March 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

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