Chronic Kidney DiseasesNCT03182517
Parathyroid Hyperplasia in Patients With Chronic Kidney Disease.
An observational study of Chronic Kidney Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Secondary hyperparathyroidism is an important complication in patient with chronic kidney disease . It is associated with bone complication and an increase in cardiovascular mortality The parathyroid hormone rises in these patients as consequence of low concentration of vitamin D3 ,reduction in quantities of serum… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to Nov 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with chronic renal diseases
Who may be able to join
- stage 5 chronic renal failure
- dialysis (peritoneal ,or hemodialysis) since 3---5 years
Who cannot join
- previous of neck surgery.
- Patients refusal to participate in the study or voluntary withdrawal
Trial locations and contacts
1 site in 1 country.
Ahmed Abbas contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut Faculty of Medicine
Asyut
Ahmed Abbas, MD, 0100, bmr90@hotmail.com
About this study
Official title: Correlation of Parathyroid Hyperplasia by Ultrasound With Clinical and Laboratory Findings in Patients With Chronic Kidney Disease.
Secondary hyperparathyroidism is an important complication in patient with chronic kidney disease . It is associated with bone complication and an increase in cardiovascular mortality The parathyroid hormone rises in these patients as consequence of low concentration of vitamin D3 ,reduction in quantities of serum calcium, phosphorus retention and reduction of vitamin D receptors sensitive to calcium.
- Conditions
- Chronic Kidney Diseases
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic kidney diseases | patients with chronic renal failure on dialysis since 3-5 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with high parathyroid hormone level
laboratory measurement of parathyroid hormone
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Feb 2018
- Primary completionAug 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182517
- Sponsor's protocol ID
- PTH
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2017
- Last updated
- 27 Jun 2018
- 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 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Parathyroid Hyperplasia by Ultrasound With Clinical and Laboratory Findings in Patients With Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT03182517
- Acronym / sponsor ID
- PTH
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 9 Jun 2017 (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.
Secondary hyperparathyroidism is an important complication in patient with chronic kidney disease . It is associated with bone complication and an increase in cardiovascular mortality The parathyroid hormone rises in these patients as consequence of low concentration of vitamin D3 ,reduction in quantities of serum calcium, phosphorus retention and reduction of vitamin D receptors sensitive to calcium.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic kidney diseases | – | –patients with chronic renal failure on dialysis since 3-5 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with chronic renal diseases
Key inclusion criteria (2 listed)
- stage 5 chronic renal failure
- dialysis (peritoneal ,or hemodialysis) since 3---5 years
Key exclusion criteria (2 listed)
- previous of neck surgery.
- Patients refusal to participate in the study or voluntary withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of patients with high parathyroid hormone level
Time frame: 1 day
laboratory measurement of parathyroid hormone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Ahmed Abbas contact
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 Chronic Kidney Diseases, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abbas (01003385183, bmr90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with high parathyroid hormone level (time frame: 1 day). 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 27 Jun 2018.