NCT02338128

Brief Summary

The purpose of this study is to determine whether Febuxostat could protect cardiovascular function of peritoneal dialysis patients by lowering serum uric acid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

January 9, 2015

Last Update Submit

July 23, 2019

Conditions

Disorders Associated With Peritoneal DialysisHyperuricemia

Keywords

peritoneal dialysishyperuricemiacardiovascularFebuxostat

Outcome Measures

Primary Outcomes (1)

  • cardiovascular events (heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.)

    heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.

    1 year

Secondary Outcomes (2)

  • Serum uric acid

    1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month

  • cardiovascular function (Heart construction and cardiac ejection fraction determined by echocardiography; blood test: cardiac markers including troponin,myoglobin and creatinine kinase, MB isoenzyme (CK-MB), brain natriuretic peptide)

    6 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Peritoneal dialysis patients with hyperuricemia

You may qualify if:

  • \- Peritoneal dialysis for more than 3 months with hyperuricemia.

You may not qualify if:

  • Acute hepatopathy or liver dysfunction (Aspartate transaminase and/or alanine aminotransferase exceed 2 times of normal range)
  • Heart failure (stage IV, NYHA), unstable angina, acute stroke
  • Severe lung disease or cancer
  • unable to sign the informed consent form or disagree following-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ling Wang, MD, PhD

    Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of department of Nephrology & Rheumatology

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

CN(1)