We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Hyperuricaemia on Chronic Renal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03425708
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
The First People's Hospital of Xuzhou
Information provided by (Responsible Party):
The Affiliated Hospital of Xuzhou Medical University

Brief Summary:
To investigate the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

Condition or disease Intervention/treatment Phase
Hyperuricemia Chronic Renal Disease Drug: 20mg Febuxostat Drug: 40mg Febuxostat Phase 4

Detailed Description:
This study aims to explore the best effective dose and adverse reaction of febuxostat in lowering serum uric acid to low level in patients with Chronic Renal Disease at different stages. To elucidate that low levels of serum uric acid can delay the progression of renal damage. Promote the application of anti uric acid drugs in the treatment of chronic renal failure and delay the progress of CKD in patients

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study on the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Febuxostat
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Treatment group1
Febuxostat pill 20mg was used to treat CKD patients with hyperuricaemia.
Drug: 20mg Febuxostat
Participants take 20mg febuxostat pill once a day for at least six months.
Other Name: 20mg Febuxostat pill group
Active Comparator: Treatment group2
Febuxostat pill 40mg was used to treat CKD patients with hyperuricaemia.
Drug: 40mg Febuxostat
Participants take 40mg febuxostat pill once a day for at least six months.
Other Name: 40mg Febuxostat pill group
No Intervention: Control group
Treatment of CKD patients with hyperuricaemia with conventional methods.



Primary Outcome Measures :
  1. serum uric acid [ Time Frame: up to 6 months ]
    intravenous blood sampling


Secondary Outcome Measures :
  1. serum creatinine [ Time Frame: up to 6 months ]
    intravenous blood sampling



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-dialysis CKD patients with serum uric acid greater than 7mg/dl.
  • eGFR≥15ml/min/1.73m².
  • Low salt, low protein, low purine diet.

Exclusion Criteria:

  • Take drugs that raise blood uric acid at the same time.
  • Patients with gout attacks.
  • Patients with pregnant, lactating.
  • Autosomal dominant polycystic kidney disease.
  • Patients with poor general condition and multiple organ failure.

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): NCT03425708


Contacts
Contact: Dong Sun, MD 15862158578 sundong126@yahoo.com

Locations
China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Dong Sun, MD    15862158578    sundong126@yahoo.com   
Sponsors and Collaborators
The Affiliated Hospital of Xuzhou Medical University
The First People's Hospital of Xuzhou
Investigators
Study Director: Dong Sun, MD Affiliated Hospital of Xuzhou Medical University

Publications:

Responsible Party: The Affiliated Hospital of Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03425708     History of Changes
Other Study ID Numbers: XYFY2017-KL043-01
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by The Affiliated Hospital of Xuzhou Medical University:
Uric Acid
Febuxostat
Chronic Renal Disease

Additional relevant MeSH terms:
Kidney Diseases
Hyperuricemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Pathologic Processes
Renal Insufficiency
Febuxostat
Gout Suppressants
Antirheumatic Agents