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NCT03425708 Clinical Trial

Effect of Hyperuricaemia on Chronic Renal Disease

Hyperuricemia Clinical Trial

Official title:
Study on the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03425708
Other study ID # XYFY2017-KL043-01
Secondary ID
Status Recruiting
Phase Phase 4
First received January 13, 2018
Last updated February 6, 2018
Start date January 1, 2017
Est. completion date December 31, 2018

Study information
Verified date January 2018
Source The Affiliated Hospital of Xuzhou Medical University
Contact Dong Sun, MD
Phone 15862158578
Email sundong126@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu

Sponsors (2)
Lead Sponsor Collaborator
The Affiliated Hospital of Xuzhou Medical University The First People's Hospital of Xuzhou

Country where clinical trial is conducted

China, 

References & Publications (17)

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

Falvello LR, Fernández 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. — View Citation

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. — View Citation

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. Review. — View 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. — View Citation

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. Review. — View 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. Review. — View Citation

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. — View 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. Review. — View 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. Epub 2006 Jun 14. — View Citation

Sánchez-Lozada LG, Tapia E, Santamaría J, Avila-Casado C, Soto V, Nepomuceno T, Rodríguez-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. — View 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. Review. German. — View Citation

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. 2017 Nov 10. pii: S0272-6386(17)30948-4. doi: 10.1053/j.ajkd.2017.08.017. [Epub ahead of print] — View 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. Review. — View Citation

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. — View 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. — View 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;18:26. doi: 10.1186/2047-783X-18-26. Retraction in: Eur J Med Res. 2015;20:44. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary serum uric acid intravenous blood sampling up to 6 months
Secondary serum creatinine intravenous blood sampling up to 6 months
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