NCT04013139

Brief Summary

Reductions in exercise capacity associated with exercise intolerance augment cardiovascular disease risk and predict mortality in chronic kidney disease. This study utilized cardiopulmonary exercise testing to (a) investigate mechanisms of exercise intolerance; (b) unmask subclinical ca and p and vitamin D abnormalities that may precede cardiovascular disease in chronic kidney disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

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

First Submitted

Initial submission to the registry

June 23, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

June 23, 2019

Last Update Submit

January 27, 2022

Conditions

Ckd-Mbd

Outcome Measures

Primary Outcomes (2)

  • Calcium x phosphorus change in stage 3-5

    CaxP change

    12 MONTHS

  • CPET score change

    Evaluation of CPET score change

    12 MONTHS

Secondary Outcomes (1)

  • Renal Function change

    12 MONTHS

Study Arms (2)

CKD Stage 3

CKD patients with GFR between 30-60cc/min

Diagnostic Test: CPET

CKD Stage 4

CKD Patients with GFR 15-30 cc/min

Diagnostic Test: CPET

Interventions

CPETDIAGNOSTIC_TEST

CPET

CKD Stage 3CKD Stage 4

Eligibility Criteria

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

All \>18 years CKD Patients with GFR \<60 non-dialysis

You may qualify if:

  • CKD Patients with GFR \<60 non-dialysis
  • age\<18

You may not qualify if:

  • HTN
  • not signing consent
  • active coronary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nooshin Dalili

Tehran, Iran

Location

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

RicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dalili

    SBMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2019

First Posted

July 9, 2019

Study Start

January 1, 2020

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)