NCT03194087

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
827

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

May 31, 2017

Last Update Submit

June 20, 2017

Conditions

Secondary Hyperparathyroidism

Keywords

Secondary HyperparathyroidismLow parathyroid hormoneHemodialysis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    all of the patients will be followed for 24 months to compare the all-cause mortality.

    24 months

Secondary Outcomes (1)

  • the rate of cardiovascular and cerebrovascular events.

    24 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryHypoparathyroidism

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • WenHu Liu, doctor

    Beijing Friendship Hospital

    STUDY CHAIR

Central Study Contacts

Zongli Diao, doctor

CONTACT

+86-01-63138579diaoted@163.com

Study Design

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

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 21, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)