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HyperuricemiaPhase 4NCT03425708

Effect of Hyperuricaemia on Chronic Renal Disease

A Phase 4 study testing 20mg Febuxostat and 40mg Febuxostat in people with Hyperuricemia and Chronic Renal Disease, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hyperuricemia, Chronic Renal Disease
What is being tested?
20mg Febuxostat and 40mg Febuxostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
1 Jan 2017to 31 Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Dong Sun, MD contact

15862158578

sundong126@yahoo.com

China1 site, 1 recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

    Dong Sun, MD, 15862158578, sundong126@yahoo.com

    Recruiting

Other trials in China

About this study

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

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

Read the 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

Being tested
20mg Febuxostat, 40mg Febuxostat
Keywords
Uric Acid, Febuxostat, Chronic Renal Disease
Medical subject headings
Hyperuricemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20mg FebuxostatDrug

    Also called 20mg Febuxostat pill group

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

  • 40mg FebuxostatDrug

    Also called 40mg Febuxostat pill group

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

Study groups in NCT03425708
Study groupRoleWhat they receive
Treatment group1Active comparatorFebuxostat pill 20mg was used to treat CKD patients with hyperuricaemia.
Receives: Drug: 20mg Febuxostat
Treatment group2Active comparatorFebuxostat pill 40mg was used to treat CKD patients with hyperuricaemia.
Receives: Drug: 40mg Febuxostat
Control groupNo interventionTreatment of CKD patients with hyperuricaemia with conventional methods.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. serum uric acid

    intravenous blood sampling

    Measured: up to 6 months

Secondary outcomes (1)

  1. serum creatinine

    intravenous blood sampling

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start1 Jan 2017
  3. Primary completion31 Dec 2018 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03425708
Sponsor's protocol ID
XYFY2017-KL043-01
Status last verified
Jan 2018
First submitted
13 Jan 2018
Last updated
7 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26414733

  • 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.

    PubMed 23895583

  • 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.

    PubMed 25998500

  • 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.

    PubMed 16775029

  • 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.

    PubMed 15840020

  • 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.

    PubMed 25962453

  • 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.

    PubMed 26414732

  • 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.

    PubMed 28082903

  • 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.

    PubMed 26414731

  • 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.

    PubMed 27713539

  • 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.

    PubMed 15610247

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

    PubMed 19339923

  • 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.

    PubMed 27339448

  • 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.

    PubMed 29132945

  • 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.

    PubMed 11232839

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 20mg Febuxostat and 40mg Febuxostat in people with Hyperuricemia and Chronic Renal Disease, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dong Sun, MD (15862158578, sundong126@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

serum uric acid (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03425708, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.

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