NCT07199205

Brief Summary

Chronic kidney disease (CKD) is a major global health problem, and hyperuricemia has emerged as both a consequence and a potential driver of its progression. Elevated uric acid contributes to renal impairment through oxidative stress, endothelial dysfunction, inflammasome activation, and crystal deposition. Epidemiological studies show that hyperuricemia often precedes CKD and serves as an independent predictor, with prevalence reaching up to 38% among CKD patients. Prediabetes, another growing health concern, is associated with higher serum uric acid levels and increased risk of developing both diabetes and CKD. Factors such as obesity, fatty liver, and dyslipidemia mediate this link. Clinically, higher uric acid levels are correlated with faster eGFR decline and higher risk of ESRD, with the uric acid/HDL ratio proposed as a novel risk marker. Although debate persists about whether hyperuricemia directly causes CKD, emerging genetic and epidemiological evidence supports its independent role. Given the rising prevalence of prediabetes and hyperuricemia, identifying hyperuricemia as a modifiable early predictor of CKD progression in prediabetic patients could help improve prevention, risk stratification, and management

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Jan 2027

First Submitted

Initial submission to the registry

September 19, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 19, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

CKDPrediabetesHyperuricemia

Outcome Measures

Primary Outcomes (1)

  • CKD progression in prediabetics

    Progression of CKD, defined as a sustained reduction in eGFR of ≥25% from baseline or advancement to a higher CKD stage (KDIGO classification) during the follow-up period.

    1 year

Study Arms (3)

Group 1

includes individuals at high risk of chronic kidney disease (prediabetic patient s)

Group 2

individuals diagnosed with early ckd stage A1,A2,A3

Group 3

serves as the control group and includes participants with normal renal function.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population divided into three groups: The first group includes individuals at high risk of chronic kidney disease (prediabetic patient s) The second group comprises individuals diagnosed with early ckd stage A1,A2,A3 The third group serves as the control group and includes participants with normal renal function

You may qualify if:

  • Adults aged 18 years and older.
  • Diagnosed with prediabetes, defined according to the American Diabetes - - - - Association (ADA) criteria (fasting plasma glucose 100-125 mg/dL, HbA1c 5.7-6.4%, or 2-hour plasma glucose 140-199 mg/dL after oral glucose tolerance test).
  • Baseline estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (CKD stages 1-2).
  • Willingness to provide informed consent and comply with study procedures.

You may not qualify if:

  • Diagnosis of diabetes mellitus (fasting plasma glucose ≥126 mg/dL, HbA1c ≥6.5%).
  • Established CKD stage 3 or higher (eGFR \<60 mL/min/1.73 m²).
  • History of gout or current use of uric acid-lowering therapy (e.g., allopurinol, febuxostat) or acute gout.
  • Use of medications known to significantly affect uric acid levels (e.g., thiazide diuretics, high-dose aspirin).
  • Pregnancy or lactation.
  • Presence of severe comorbid conditions (e.g., malignancy, active infection, advanced liver disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Johnson MR, Costanzo-Nordin MR, Heroux AL, Kao WG, Mullen GM, Pifarre R, Sullivan HJ. High-risk cardiac operation: a viable alternative to heart transplantation. Ann Thorac Surg. 1993 Apr;55(4):876-82. doi: 10.1016/0003-4975(93)90109-u.

    PMID: 8466342BACKGROUND
  • Petro WG, Kendelewicz T, Lindau I I, Spicer WE. Au-GaAs(110) interface: Photoemission studies of the effects of temperature. Phys Rev B Condens Matter. 1986 Nov 15;34(10):7089-7106. doi: 10.1103/physrevb.34.7089. No abstract available.

    PMID: 9939362BACKGROUND
  • Bignardi PR, Ido DH, Garcia FAL, Braga LM, Delfino VDA. Does uric acid-lowering treatment slow the progression of chronic kidney disease? A meta-analysis of randomized controlled trials. Nefrologia (Engl Ed). 2023 Mar-Apr;43(2):167-181. doi: 10.1016/j.nefroe.2022.04.005. Epub 2022 Dec 21.

    PMID: 36564223BACKGROUND
  • 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: 29132945BACKGROUND
  • Galan I, Goicoechea M, Quiroga B, Macias N, Santos A, Garcia de Vinuesa MS, Verdalles U, Cedeno S, Verde E, Perez de Jose A, Garcia A, Luno J. Hyperuricemia is associated with progression of chronic kidney disease in patients with reduced functioning kidney mass. Nefrologia (Engl Ed). 2018 Jan-Feb;38(1):73-78. doi: 10.1016/j.nefro.2017.04.006. Epub 2017 Aug 30. English, Spanish.

    PMID: 28869042BACKGROUND
  • Johnson RJ, Sanchez Lozada LG, Lanaspa MA, Piani F, Borghi C. Uric Acid and Chronic Kidney Disease: Still More to Do. Kidney Int Rep. 2022 Dec 5;8(2):229-239. doi: 10.1016/j.ekir.2022.11.016. eCollection 2023 Feb.

    PMID: 36815099BACKGROUND
  • Hung YH, Huang CC, Lin LY, Chen JW. Uric Acid and Impairment of Renal Function in Non-diabetic Hypertensive Patients. Front Med (Lausanne). 2022 Jan 24;8:746886. doi: 10.3389/fmed.2021.746886. eCollection 2021.

    PMID: 35141237BACKGROUND
  • Alqahtani SAM, Awan ZA, Alasmary MY, Al Amoudi SM. Association between serum uric acid with diabetes and other biochemical markers. J Family Med Prim Care. 2022 Apr;11(4):1401-1409. doi: 10.4103/jfmpc.jfmpc_1833_21. Epub 2022 Mar 18.

    PMID: 35516683BACKGROUND
  • Echouffo-Tcheugui JB, Narayan KM, Weisman D, Golden SH, Jaar BG. Association between prediabetes and risk of chronic kidney disease: a systematic review and meta-analysis. Diabet Med. 2016 Dec;33(12):1615-1624. doi: 10.1111/dme.13113. Epub 2016 Apr 24.

    PMID: 26997583BACKGROUND
  • Beaucher WN. How the wheels of "justice" nearly destroyed an innocent doctor. Med Econ. 1993 Nov 22;70(22):170-6. No abstract available.

    PMID: 10130409BACKGROUND

MeSH Terms

Conditions

Prediabetic StateHyperuricemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor in Internal medicine department

Study Record Dates

First Submitted

September 19, 2025

First Posted

September 30, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

September 30, 2025

Record last verified: 2025-09