Secondary HyperparathyroidismNCT03194087
the Study on Prognostic for Hemodialysis Patients
An observational study of Secondary Hyperparathyroidism, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Results from KDOQI guidelines, parathyroid hormone (PTH) level within target range is 150-300pg/ml. Both lower PTH levels and higher PTH levels were associated with higher risk of all-cause mortality. However, in out of target range, it is still unknown which mortality higher. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Secondary Hyperparathyroidism
- How many people
- 827 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jan 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. patients with age between 18-75 years. 2. patients in hemodialysis, whose iPTH is below 300pg/ml or above 800pg/ml.
Who may be able to join
- patients with age between 18-75 years.
- patients in hemodialysis, whose iPTH is below 300pg/ml or above 800pg/ml.
Who cannot join
- primary or tertiary hyperparathyroidism(hyperparathyroidism after kidney transplantation).
- pregnant or lactating woman.
- patients with severe liver disease and abnormal blood clotting mechanism.
- patients with chronic wasting disease.
- patients whose concurrent illnesses,disability,or geographical residence would hamper attendance at required study visit.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship hospital
Beijing, Beijing Municipality, 100050
Wenhu Liu, Doctor, +86-01-63139144, liuwh2002@yahoo.cn
Wenhu Liu, Doctor
About this study
Official title: the Study on Difference Prognostic for Low Parathyroid Hormone Levels and Severe Secondary Hyperparathyroidism in Hemodialysis Patients
Results from KDOQI guidelines, parathyroid hormone (PTH) level within target range is 150-300pg/ml. Both lower PTH levels and higher PTH levels were associated with higher risk of all-cause mortality. However, in out of target range, it is still unknown which mortality higher. so, in this prospective, observational clinical trial study. the investigators will observe the mortality and cardiovascular incidence rate between SHPT(>800pg/ml) and low serum PTH levels(<60pg/ml). Both two groups of patients will receive a reasonable treatment according to the suggestions in K/DOQI guidelines.
Read the detailed description
It is common that the abnormalities in parathyroid hormone (PTH) levels appear in patients with moderate and advanced chronic kidney diseases (CKD). CKD-mineral and bone disorder (CKD-MBD), manifested by the serum calcium (Ca), phosphorus (P), and parathyroid hormone (PTH) levels, and other abnormalities such as vitamin D metabolism and bone turnover etc, contribute to the increased morbidity and mortality in patients on maintenance dialysis.
Results from KDOQI guidelines, indicated that an increased mortality risk was associated with high parathyroid hormone (PTH) levels, if the PTH levels >600pg/ml, it means severe secondary hyperparathyroidism, it have been shown to contribute to alterations of arterial structure and function and associated with cardiovascular (CV), calcifications, CV events, and death.
In most patients, SHPT can be successfully controlled by dialysis and supplements of calcium and vitamin D. but Results from several studies, the severe secondary hyperparathyroidism can't be control by medical treatment or hemodialysis, about 15% of patients after 10 years and 38% of patients after 20 years of dialysis need parathyroidectomy. total parathyroidectomy(tPTX) is the best Surgical approach. tPTX seems to be associated to a lower relapse rate but higher percentage of hypoparathyroidism. But it may cause the patient in low parathyroid hormone status.
It is well known that at present, a high proportion of patients receiving dialysis therapy have relatively low serum PTH levels. In parallel, the observation that CV calcifications are more prevalent in patients undergoing dialysis who have low serum PTH levels than in those with normal or moderately elevated levels, in association with low-turnover bone disease, this condition favors mineral deposition in vascular and other soft tissues instead of bone. Results from several studies, all of them reported an increase in CV mortality risk in patients with low PTH levels.
Nonetheless, consistent evidence associating Compare SHPT with low serum PTH levels which mortality rate is higher in patients undergoing dialysis is still lacking. so, in this prospective, observational clinical trial study. the investigators will observe the mortality and CV incidence rate between SHPT and low serum PTH levels. the investigators detect the iPTH levels of all the patients in the investigators' blood purification center. The patients whose iPTH are Less than 300pg/ml and more than the 800pg/ml are chosen to involve in this study. According to PTH levels The patients will be divided into two groups. Both two groups of patients will receive a reasonable treatment according to the suggestions in K/DOQI guidelines. Then, all of the patients will be followed for 24 months to compare the rate of cardiovascular and cerebrovascular events and mortality in each group.
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Secondary Hyperparathyroidism, Low parathyroid hormone, Hemodialysis
- Medical subject headings
- Hyperparathyroidism, Secondary, Hypoparathyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
all of the patients will be followed for 24 months to compare the all-cause mortality.
Measured: 24 months
Secondary outcomes (1)
the rate of cardiovascular and cerebrovascular events.
all of the patients will be followed for 24 months to compare the rate of cardiovascular and cerebrovascular events.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 827 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhu Liu, Beijing Friendship Hospital
- Investigators
- WenHu Liu, doctor, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194087
- Sponsor's protocol ID
- 2016-P2-044-01
- Status last verified
- Jun 2017
- First submitted
- 31 May 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Study on Difference Prognostic for Low Parathyroid Hormone Levels and Severe Secondary Hyperparathyroidism in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03194087
- Acronym / sponsor ID
- 2016-P2-044-01
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Secondary Hyperparathyroidism, Low parathyroid hormone, Hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 827 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 21 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.
Results from KDOQI guidelines, parathyroid hormone (PTH) level within target range is 150-300pg/ml. Both lower PTH levels and higher PTH levels were associated with higher risk of all-cause mortality. However, in out of target range, it is still unknown which mortality higher. so, in this prospective, observational clinical trial study. the investigators will observe the mortality and cardiovascular incidence rate between SHPT(>800pg/ml) and low serum PTH levels(<60pg/ml). Both two groups of patients will receive a reasonable treatment according to the suggestions in K/DOQI guidelines.
Detailed description
It is common that the abnormalities in parathyroid hormone (PTH) levels appear in patients with moderate and advanced chronic kidney diseases (CKD). CKD-mineral and bone disorder (CKD-MBD), manifested by the serum calcium (Ca), phosphorus (P), and parathyroid hormone (PTH) levels, and other abnormalities such as vitamin D metabolism and bone turnover etc, contribute to the increased morbidity and mortality in patients on maintenance dialysis.
Results from KDOQI guidelines, indicated that an increased mortality risk was associated with high parathyroid hormone (PTH) levels, if the PTH levels >600pg/ml, it means severe secondary hyperparathyroidism, it have been shown to contribute to alterations of arterial structure and function and associated with cardiovascular (CV), calcifications, CV events, and death.
In most patients, SHPT can be successfully controlled by dialysis and supplements of calcium and vitamin D. but Results from several studies, the severe secondary hyperparathyroidism can't be control by medical treatment or hemodialysis, about 15% of patients after 10 years and 38% of patients after 20 years of dialysis need parathyroidectomy. total parathyroidectomy(tPTX) is the best Surgical approach. tPTX seems to be associated to a lower relapse rate but higher percentage of hypoparathyroidism. But it may cause the patient in low parathyroid hormone status.
It is well known that at present, a high proportion of patients receiving dialysis therapy have relatively low serum PTH levels. In parallel, the observation that CV calcifications are more prevalent in patients undergoing dialysis who have low serum PTH levels than in those with normal or moderately elevated levels, in association with low-turnover bone disease, this condition favors mineral deposition in vascular and other soft tissues instead of bone. Results from several studies, all of them reported an increase in CV mortality risk in patients with low PTH levels.
Nonetheless, consistent evidence associating Compare SHPT with low serum PTH levels which mortality rate is higher in patients undergoing dialysis is still lacking. so, in this prospective, observational clinical trial study. the investigators will observe the mortality and CV incidence rate between SHPT and low serum PTH levels. the investigators detect the iPTH levels of all the patients in the investigators' blood purification center. The patients whose iPTH are Less than 300pg/ml and more than the 800pg/ml are chosen to involve in this study. According to PTH levels The patients will be divided into two groups. Both two groups of patients will receive a reasonable treatment according to the suggestions in K/DOQI guidelines. Then, all of the patients will be followed for 24 months to compare the rate of cardiovascular and cerebrovascular events and mortality in each group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. patients with age between 18-75 years. 2. patients in hemodialysis, whose iPTH is below 300pg/ml or above 800pg/ml.
Key inclusion criteria (2 listed)
- patients with age between 18-75 years.
- patients in hemodialysis, whose iPTH is below 300pg/ml or above 800pg/ml.
Key exclusion criteria (5 listed)
- primary or tertiary hyperparathyroidism(hyperparathyroidism after kidney transplantation).
- pregnant or lactating woman.
- patients with severe liver disease and abnormal blood clotting mechanism.
- patients with chronic wasting disease.
- patients whose concurrent illnesses,disability,or geographical residence would hamper attendance at required study visit.
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
All-cause mortality
Time frame: 24 months
all of the patients will be followed for 24 months to compare the all-cause mortality.
1 secondary outcome
the rate of cardiovascular and cerebrovascular events.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Secondary Hyperparathyroidism
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
RecruitingObservational study
The CPH-MBD Cohort
Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Disease (CKD)
Not yet recruitingObservational study
Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
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.
WenHu Liu, doctor study chair
Beijing Friendship Hospital
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 Secondary Hyperparathyroidism, run by Beijing Friendship Hospital at 1 site in China.
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 5 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 21 Jun 2017. 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 China. 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 Zongli Diao, doctor (+86-01-63138579, diaoted@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 24 months). 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 21 Jun 2017.