NCT03356522

Brief Summary

Observational study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

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

February 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

November 16, 2017

Last Update Submit

November 28, 2017

Conditions

Chronic Renal FailureKidney Transplant Patients

Outcome Measures

Primary Outcomes (1)

  • Value of Trabecular Bone Score (TBS)

    Baseline

Secondary Outcomes (4)

  • Evaluation of bone remodeling markers

    Baseline

  • Evaluation of bone remodeling markers

    Baseline

  • Evaluation of bone remodeling markers

    Baseline

  • Evaluation of bone remodeling markers

    Baseline

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney failure patients and kidney transplant patients

You may qualify if:

  • st population: kidney failure patients at stage 4-5, age\> 40 years, non-dialyzed, ungrafted.
  • nd population: kidney transplant patients, age\> 40, first kidney transplant.

You may not qualify if:

  • Pregnant women.
  • Incapable adults (tutelage, guardianship, safeguard of justice).
  • Persons deprived of liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, Britain, 35033, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pascal Guggenbuhl

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 29, 2017

Study Start

February 1, 2016

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

FR(1)