Effect of Hyperuricaemia on Chronic Renal Disease

NCT03425708 | Unknown Phase 4 DMC

• 1 other identifier: XYFY2017-KL043-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperuricemia; Chronic Renal Disease

Keywords

Uric Acid; Febuxostat; Chronic Renal Disease

Outcome Measures

Primary Outcomes (1)

• serum uric acid

  intravenous blood sampling

  up to 6 months

Secondary Outcomes (1)

• serum creatinine

  up to 6 months

Study Arms (3)

Treatment group1

ACTIVE COMPARATOR

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

Drug: 20mg Febuxostat

Treatment group2

ACTIVE COMPARATOR

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

Drug: 40mg Febuxostat

Control group

NO INTERVENTION

Treatment of CKD patients with hyperuricaemia with conventional methods.

Interventions

20mg Febuxostat DRUG

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

Also known as: 20mg Febuxostat pill group

Treatment group1

40mg Febuxostat DRUG

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

Also known as: 40mg Febuxostat pill group

Treatment group2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead
• The First People's Hospital of Xuzhou: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (17)

• 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.

  PMID: 26414733 BACKGROUND

• 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.

  PMID: 23895583 BACKGROUND

• 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.

  PMID: 25998500 BACKGROUND

• 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.

  PMID: 16775029 BACKGROUND

• 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.

  PMID: 15840020 BACKGROUND

• 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.

  PMID: 25962453 BACKGROUND

• 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.

  PMID: 26414732 BACKGROUND

• Miyata H, Takada T, Toyoda Y, Matsuo H, Ichida K, Suzuki H. Identification of Febuxostat as a New Strong ABCG2 Inhibitor: Potential Applications and Risks in Clinical Situations. Front Pharmacol. 2016 Dec 27;7:518. doi: 10.3389/fphar.2016.00518. eCollection 2016.

  PMID: 28082903 BACKGROUND

• 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.

  PMID: 26414731 BACKGROUND

• Tan PK, Ostertag TM, Miner JN. Mechanism of high affinity inhibition of the human urate transporter URAT1. Sci Rep. 2016 Oct 7;6:34995. doi: 10.1038/srep34995.

  PMID: 27713539 BACKGROUND

• Sanchez-Lozada LG, Tapia E, Santamaria J, Avila-Casado C, Soto V, Nepomuceno T, Rodriguez-Iturbe B, Johnson RJ, Herrera-Acosta J. Mild hyperuricemia induces vasoconstriction and maintains glomerular hypertension in normal and remnant kidney rats. Kidney Int. 2005 Jan;67(1):237-47. doi: 10.1111/j.1523-1755.2005.00074.x.

  PMID: 15610247 BACKGROUND

• Edwards NL. The role of hyperuricemia in vascular disorders. Curr Opin Rheumatol. 2009 Mar;21(2):132-7. doi: 10.1097/BOR.0b013e3283257b96.

  PMID: 19339923 BACKGROUND

• Kumagai T, Ota T, Tamura Y, Chang WX, Shibata S, Uchida S. Time to target uric acid to retard CKD progression. Clin Exp Nephrol. 2017 Apr;21(2):182-192. doi: 10.1007/s10157-016-1288-2. Epub 2016 Jun 23.

  PMID: 27339448 BACKGROUND

• Srivastava A, Kaze AD, McMullan CJ, Isakova T, Waikar SS. Uric Acid and the Risks of Kidney Failure and Death in Individuals With CKD. Am J Kidney Dis. 2018 Mar;71(3):362-370. doi: 10.1053/j.ajkd.2017.08.017. Epub 2017 Nov 11.

  PMID: 29132945 BACKGROUND

• Falvello LR, Fernandez S, Navarro R, Urriolabeitia EP. Reactivity of Pd(0) complexes with the phosphino ylide [Ph2PCH2PPh2=C(H)C(O)Me]. Molecular structure of [Pd(PPh2CHPPh2C(H)C(O)Me)2]. Inorg Chem. 2000 Jun 26;39(13):2957-60. doi: 10.1021/ic990923z. No abstract available.

  PMID: 11232839 BACKGROUND

• Kang DH, Ha SK. Uric Acid Puzzle: Dual Role as Anti-oxidantand Pro-oxidant. Electrolyte Blood Press. 2014 Jun;12(1):1-6. doi: 10.5049/EBP.2014.12.1.1. Epub 2014 Jun 30.

  PMID: 25061467 BACKGROUND

• Jalal DI, Decker E, Perrenoud L, Nowak KL, Bispham N, Mehta T, Smits G, You Z, Seals D, Chonchol M, Johnson RJ. Vascular Function and Uric Acid-Lowering in Stage 3 CKD. J Am Soc Nephrol. 2017 Mar;28(3):943-952. doi: 10.1681/ASN.2016050521. Epub 2016 Sep 12.

  PMID: 27620990 BACKGROUND

MeSH Terms

Conditions

Hyperuricemia; Renal Insufficiency, Chronic

Interventions

Febuxostat; Population Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Demography; Population Characteristics

Study Officials

• Dong Sun, MD

  The Affiliated Hospital of Xuzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Dong Sun, MD

CONTACT

15862158578; sundong126@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: February 7, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)