NCT02230202

Brief Summary

The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

August 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

August 25, 2014

Last Update Submit

February 26, 2018

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Vascular Function

    This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.

    percent change from baseline over 2 minutes

Secondary Outcomes (1)

  • Characterization of Microparticle source from blood analysis

    Single time point

Study Arms (3)

Healthy control

Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Other: Flow-mediated dilationOther: single blood draw

Stage III or IV CKD patients

Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Other: Flow-mediated dilationOther: single blood draw

Post-transplant patients

Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Other: Flow-mediated dilationOther: single blood draw

Interventions

Flow-mediated dilationOTHER

Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.

Healthy controlPost-transplant patientsStage III or IV CKD patients
single blood drawOTHER

single blood draw of approximately 45 mL.

Healthy controlPost-transplant patientsStage III or IV CKD patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

90 volunteers from the Anschutz Medical Campus

You may qualify if:

  • For Healthy controls:
  • BMI less than 40 kg/m\^2
  • Able to give informed consent
  • For Stage III or IV CKD patients:
  • BMI less than 40 kg/m\^2
  • Able to give informed consent
  • An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m\^2
  • For Post-kidney transplant and stage III or IV CKD patients:
  • BMI less than 40 kg/m\^2
  • Able to give informed consent
  • An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m\^2

You may not qualify if:

  • For Healthy controls:
  • Women pregnant or breastfeeding
  • For Stage III or IV CKD patients:
  • Women pregnant or breastfeeding
  • Adults with a life expectancy of less than one year
  • A history of significant liver disease or congestive heart failure
  • Hospitalization within the last three months
  • Active infection on antibiotic therapy
  • Uncontrolled hypertension (\>140/90)
  • Immunosuppressive therapy within the last year
  • For Post-transplant stage III or IV CKD patients:
  • Women pregnant or breastfeeding
  • Adults with a life expectancy of less than one year
  • A history of significant liver disease or congestive heart failure
  • Hospitalization within the last three months
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Anschutz Medical Campus; CTRC

Aurora, Colorado, 80045, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Jalal D, Renner B, Laskowski J, Stites E, Cooper J, Valente K, You Z, Perrenoud L, Le Quintrec M, Muhamed I, Christians U, Klawitter J, Lindorfer MA, Taylor RP, Holers VM, Thurman JM. Endothelial Microparticles and Systemic Complement Activation in Patients With Chronic Kidney Disease. J Am Heart Assoc. 2018 Jul 13;7(14):e007818. doi: 10.1161/JAHA.117.007818.

    PMID: 30006493DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and urine biospecimens to be retained.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Joshua M Thurman, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

September 3, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

US(2)