Effect of Hyperuricaemia on Chronic Renal Disease

Overview

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

Full Title of Study: “Study on the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2018

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

Interventions

  • Drug: 20mg Febuxostat
    • Participants take 20mg febuxostat pill once a day for at least six months.
  • Drug: 40mg Febuxostat
    • Participants take 40mg febuxostat pill once a day for at least six months.

Arms, Groups and Cohorts

  • Active Comparator: Treatment group1
    • Febuxostat pill 20mg was used to treat CKD patients with hyperuricaemia.
  • Active Comparator: Treatment group2
    • Febuxostat pill 40mg was used to treat CKD patients with hyperuricaemia.
  • No Intervention: Control group
    • Treatment of CKD patients with hyperuricaemia with conventional methods.

Clinical Trial Outcome Measures

Primary Measures

  • serum uric acid
    • Time Frame: up to 6 months
    • intravenous blood sampling

Secondary Measures

  • serum creatinine
    • Time Frame: up to 6 months
    • intravenous blood sampling

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Affiliated Hospital of Xuzhou Medical University
  • Collaborator
    • The First People’s Hospital of Xuzhou
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dong Sun, MD, Study Director, The Affiliated Hospital of Xuzhou Medical University
  • Overall Contact(s)
    • Dong Sun, MD, 15862158578, sundong126@yahoo.com

References

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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Edwards NL. The role of hyperuricemia in vascular disorders. Curr Opin Rheumatol. 2009 Mar;21(2):132-7. doi: 10.1097/BOR.0b013e3283257b96. Erratum In: Curr Opin Rheumatol. 2010 Jan;22(1):107.

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.

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.

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.

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.

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.

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