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Effect of Hyperuricaemia on Chronic Renal Disease

Primary Purpose

Hyperuricemia, Chronic Renal Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

20mg Febuxostat

40mg Febuxostat

About this trial

This is an interventional treatment trial for Hyperuricemia focused on measuring Uric Acid, Febuxostat, Chronic Renal Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment group1

Treatment group2

Control group

Arm Description

Febuxostat pill 20mg was used to treat CKD patients with hyperuricaemia.

Febuxostat pill 40mg was used to treat CKD patients with hyperuricaemia.

Treatment of CKD patients with hyperuricaemia with conventional methods.

Outcomes

Primary Outcome Measures

serum uric acid

intravenous blood sampling

Secondary Outcome Measures

serum creatinine

intravenous blood sampling

Full Information

NCT ID

NCT03425708

First Posted

January 13, 2018

Last Updated

February 6, 2018

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Collaborators

The First People's Hospital of Xuzhou

1. Study Identification

Unique Protocol Identification Number

NCT03425708

Brief Title

Effect of Hyperuricaemia on Chronic Renal Disease

Official Title

Study on the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Affiliated Hospital of Xuzhou Medical University

Collaborators

The First People's Hospital of Xuzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia, Chronic Renal Disease

Keywords

Uric Acid, Febuxostat, Chronic Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group1

Arm Type

Active Comparator

Arm Description

Febuxostat pill 20mg was used to treat CKD patients with hyperuricaemia.

Arm Title

Treatment group2

Arm Type

Active Comparator

Arm Description

Febuxostat pill 40mg was used to treat CKD patients with hyperuricaemia.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Treatment of CKD patients with hyperuricaemia with conventional methods.

Intervention Type

Drug

Intervention Name(s)

20mg Febuxostat

Other Intervention Name(s)

20mg Febuxostat pill group

Intervention Description

Participants take 20mg febuxostat pill once a day for at least six months.

Intervention Type

Drug

Intervention Name(s)

40mg Febuxostat

Other Intervention Name(s)

40mg Febuxostat pill group

Intervention Description

Participants take 40mg febuxostat pill once a day for at least six months.

Primary Outcome Measure Information:

Title

serum uric acid

Description

intravenous blood sampling

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

serum creatinine

Description

intravenous blood sampling

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong Sun, MD

Phone

15862158578

sundong126@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong Sun, MD

Organizational Affiliation

The Affiliated Hospital of Xuzhou Medical University

Official's Role

Study Director

Facility Information:

Facility Name

The Affiliated Hospital of Xuzhou Medical University

City

Xuzhou

State/Province

Jiangsu

ZIP/Postal Code

221000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong Sun, MD

Phone

15862158578

sundong126@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26414733

Citation

Stack A, Manolis AJ, Ritz E. Detrimental role of hyperuricemia on the cardio-reno-vascular system. Curr Med Res Opin. 2015;31 Suppl 2:21-6. doi: 10.1185/03007995.2015.1087984.

Results Reference

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PubMed Identifier

23895583

Citation

Wang Y, Bao X. Effects of uric acid on endothelial dysfunction in early chronic kidney disease and its mechanisms. Eur J Med Res. 2013 Jul 30;18(1):26. doi: 10.1186/2047-783X-18-26.

Results Reference

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PubMed Identifier

25998500

Citation

Tsuruta Y, Kikuchi K, Tsuruta Y, Sasaki Y, Moriyama T, Itabashi M, Takei T, Uchida K, Akiba T, Tsuchiya K, Nitta K. Febuxostat improves endothelial function in hemodialysis patients with hyperuricemia: A randomized controlled study. Hemodial Int. 2015 Oct;19(4):514-20. doi: 10.1111/hdi.12313. Epub 2015 May 21.

Results Reference

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PubMed Identifier

16775029

Citation

Price KL, Sautin YY, Long DA, Zhang L, Miyazaki H, Mu W, Endou H, Johnson RJ. Human vascular smooth muscle cells express a urate transporter. J Am Soc Nephrol. 2006 Jul;17(7):1791-5. doi: 10.1681/ASN.2006030264. Epub 2006 Jun 14.

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PubMed Identifier

15840020

Citation

Khosla UM, Zharikov S, Finch JL, Nakagawa T, Roncal C, Mu W, Krotova K, Block ER, Prabhakar S, Johnson RJ. Hyperuricemia induces endothelial dysfunction. Kidney Int. 2005 May;67(5):1739-42. doi: 10.1111/j.1523-1755.2005.00273.x.

Results Reference

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PubMed Identifier

25962453

Citation

Sellin L, Kielstein JT, de Groot K. [Hyperuricemia - more than gout : Impact on cardiovascular risk and renal insufficiency]. Z Rheumatol. 2015 May;74(4):322-8. doi: 10.1007/s00393-014-1481-1. German.

Results Reference

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PubMed Identifier

26414732

Citation

Mancia G, Grassi G, Borghi C. Hyperuricemia, urate deposition and the association with hypertension. Curr Med Res Opin. 2015;31 Suppl 2:15-9. doi: 10.1185/03007995.2015.1087981.

Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

26414731

Citation

Perez-Ruiz F, Becker MA. Inflammation: a possible mechanism for a causative role of hyperuricemia/gout in cardiovascular disease. Curr Med Res Opin. 2015;31 Suppl 2:9-14. doi: 10.1185/03007995.2015.1087980.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Citation

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Effect of Hyperuricaemia on Chronic Renal Disease

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