Ckd-MbdNCT04013139
Relationship Between Cardiopulmonary Exercise Testing and Ca-P in Chronic Kidney Disease (CKD)
An observational study of Ckd-Mbd, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ckd-Mbd
- What is being tested?
- CPET
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2020to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All >18 years CKD Patients with GFR <60 non-dialysis
Who may be able to join
- CKD Patients with GFR <60 non-dialysis
- age<18
Who cannot join
- HTN
- not signing consent
- active coronary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Cardiopulmonary Exercise Testing (CPET ) Abnormalities and Ca-P Status in CKD Stage3-5
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.
Read the detailed description
Cardiopulmonary exercise testing will carry out in Stage 3-5 chronic kidney disease patients ; estimated glomerular filtration rate <60 ml/min/1.73 m2) and biochemistry will be added (Ca P Via D PTH FGF23).
- Conditions
- Ckd-Mbd
- Being tested
- CPET
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPETDiagnostic test
CPET
| Study group | Role | What they receive |
|---|---|---|
| CKD Stage 3 | CKD patients with GFR between 30-60cc/min Receives: Diagnostic Test: CPET | |
| CKD Stage 4 | CKD Patients with GFR 15-30 cc/min Receives: Diagnostic Test: CPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium x phosphorus change in stage 3-5
CaxP change
Measured: 12 MONTHS
CPET score change
Evaluation of CPET score change
Measured: 12 MONTHS
Secondary outcomes (1)
Renal Function change
GFR change
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jan 2020
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ckd-MbdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- Dalili, Principal investigator, SBMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013139
- Sponsor's protocol ID
- SBMU2314
- Status last verified
- Jan 2022
- First submitted
- 23 Jun 2019
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Cardiopulmonary Exercise Testing (CPET ) Abnormalities and Ca-P Status in CKD Stage3-5
- ClinicalTrials.gov ID
- NCT04013139
- Acronym / sponsor ID
- SBMU2314
- Conditions
- Ckd-Mbd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiopulmonary exercise testing will carry out in Stage 3-5 chronic kidney disease patients ; estimated glomerular filtration rate <60 ml/min/1.73 m2) and biochemistry will be added (Ca P Via D PTH FGF23).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD Stage 3 | – | Diagnostic Test: CPETCKD patients with GFR between 30-60cc/min |
| CKD Stage 4 | – | Diagnostic Test: CPETCKD Patients with GFR 15-30 cc/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All >18 years CKD Patients with GFR <60 non-dialysis
Key inclusion criteria (2 listed)
- CKD Patients with GFR <60 non-dialysis
- age<18
Key exclusion criteria (3 listed)
- HTN
- not signing consent
- active coronary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPETCPET | Diagnostic test | CKD Stage 3, CKD Stage 4 |
Primary outcome
Calcium x phosphorus change in stage 3-5
Time frame: 12 MONTHS
CaxP change
CPET score change
Time frame: 12 MONTHS
Evaluation of CPET score change
1 secondary outcome
Renal Function change
Time frame: 12 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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Strategies for Proactive Health in People With Kidney Function Decline
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Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
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The CPH-MBD Cohort
Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Disease (CKD)
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Medium Cut-Off and High-Flux Membranes on Mineral and Bone Metabolism in Hemodialysis Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalili principal investigator
SBMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ckd-Mbd, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium x phosphorus change in stage 3-5 (time frame: 12 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.