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the Study on Prognostic for Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT03194087
Recruitment Status : Unknown
Verified June 2017 by Wenhu Liu, Beijing Friendship Hospital.
Recruitment status was:  Recruiting
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Wenhu Liu, Beijing Friendship Hospital

Brief 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. 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.

Condition or disease
Secondary Hyperparathyroidism

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.


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Study Type : Observational
Estimated Enrollment : 827 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: the Study on Difference Prognostic for Low Parathyroid Hormone Levels and Severe Secondary Hyperparathyroidism in Hemodialysis Patients
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 24 months ]
    all of the patients will be followed for 24 months to compare the all-cause mortality.


Secondary Outcome Measures :
  1. the rate of cardiovascular and cerebrovascular events. [ Time Frame: 24 months ]
    all of the patients will be followed for 24 months to compare the rate of cardiovascular and cerebrovascular events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  1. patients with age between 18-75 years.
  2. patients in hemodialysis, whose iPTH is below 300pg/ml or above 800pg/ml.
Criteria

Inclusion Criteria:

  1. patients with age between 18-75 years.
  2. patients in hemodialysis, whose iPTH is below 300pg/ml or above 800pg/ml.

Exclusion Criteria:

  1. primary or tertiary hyperparathyroidism(hyperparathyroidism after kidney transplantation).
  2. pregnant or lactating woman.
  3. patients with severe liver disease and abnormal blood clotting mechanism.
  4. patients with chronic wasting disease.
  5. patients whose concurrent illnesses,disability,or geographical residence would hamper attendance at required study visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194087


Contacts
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Contact: Zongli Diao, doctor +86-01-63138579 diaoted@163.com

Locations
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China, Beijing
Beijing Friendship hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Wenhu Liu, Doctor    +86-01-63139144    liuwh2002@yahoo.cn   
Principal Investigator: Wenhu Liu, Doctor         
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
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Study Chair: WenHu Liu, doctor Beijing Friendship Hospital

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Responsible Party: Wenhu Liu, Professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03194087     History of Changes
Other Study ID Numbers: 2016-P2-044-01
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenhu Liu, Beijing Friendship Hospital:
Secondary Hyperparathyroidism
Low parathyroid hormone
Hemodialysis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Parathyroid Hormone
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents