CKD ProgressionNCT07199205
Hyperuricemia as Early Indication of CKD Progressing in Prediabetic
An observational study of CKD Progression, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CKD Progression
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Hyperuricemia as a Predictor of Chronic Kidney Disease (CKD) Progression in Prediabetic Patients
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
Read the detailed description
Chronic kidney disease (CKD) is a global health concern, characterized by a gradual loss of kidney function, and is associated with increased morbidity and mortality. Hyperuricemia, defined as elevated serum uric acid levels, has been identified as both a consequence and a potential contributor to CKD progression. Recent studies have shown that hyperuricemia can aggravate renal impairment through mechanisms such as direct nephrotoxicity, activation of the inflammasome, increased oxidative stress, and endothelial dysfunction.
Epidemiological evidence indicates that hyperuricemia often precedes the development of CKD and may serve as an independent predictor of its onset and progression, even after adjusting for traditional risk factors like hypertension, proteinuria, and dyslipidemia. The prevalence of hyperuricemia is notably higher among CKD patients, reaching up to 38% in some populations. Furthermore, hyperuricemia is implicated in the pathogenesis of several metabolic disorders, including hypertension, obesity, and metabolic syndrome, all of which are risk factors for CKD.
Prediabetes, a state of impaired glucose metabolism, is increasingly recognized as a risk factor for both cardiovascular disease and CKD. Studies have found that individuals with prediabetes exhibit higher serum uric acid levels compared to normoglycemic individuals, and that elevated uric acid is associated with increased risk of progression to diabetes and CKD. The relationship between hyperuricemia and prediabetes appears to be mediated by factors such as fatty liver, dyslipidemia, and body mass index, highlighting the complex interplay between metabolic health and kidney function.
Clinical research has demonstrated that higher serum uric acid levels are associated with a more rapid decline in estimated glomerular filtration rate (eGFR) and an increased risk of progression to end-stage renal disease (ESRD). For example, a baseline uric acid level of ≥7.5 mg/dL has been shown to significantly increase the risk of renal function decline in hypertensive and non-diabetic populations. Additionally, the serum uric acid to high-density lipoprotein (HDL) cholesterol ratio has emerged as a novel marker for predicting CKD risk, reflecting the balance between pro-inflammatory and anti-inflammatory processes.
Despite these associations, the causality of hyperuricemia in CKD progression remains a topic of debate, as some clinical trials have yielded conflicting results regarding the benefits of uric acid-lowering therapy in slowing CKD progression. However, recent genetic and epidemiological studies suggest that hyperuricemia represents a significant risk factor for CKD, independent of genetic predisposition and other comorbidities. The mechanisms by which uric acid may induce kidney injury include crystal deposition, oxidative stress, activation of the renin-angiotensin-aldosterone system, and impairment of endothelial function.The burden of CKD in prediabetic individuals is of particular concern, as early identification of modifiable risk factors such as hyperuricemia could facilitate timely interventions to prevent or delay CKD progression. Given the increasing prevalence of both prediabetes and hyperuricemia worldwide, understanding their interplay is crucial for developing effective preventive strategies.
Despite growing evidence linking hyperuricemia to CKD progression, particularly in at-risk populations such as prediabetic patients, the predictive value of elevated serum uric acid for CKD progression in this group remains underexplored. This study aims to clarify whether hyperuricemia can serve as an early and independent predictor of CKD progression in prediabetic patients, thereby informing clinical practice and guiding risk stratification and management in this vulnerable population
- Conditions
- CKD Progression
- Keywords
- CKD, Prediabetes, Hyperuricemia
- Medical subject headings
- Prediabetic State, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CKD ProgressionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherry Refaat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199205
- Sponsor's protocol ID
- CKD progression in prediabetic
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee TH, Chen JJ, Wu CY, Yang CW, Yang HY. Hyperuricemia and Progression of Chronic Kidney Disease: A Review from Physiology and Pathogenesis to the Role of Urate-Lowering Therapy. Diagnostics (Basel). 2021 Sep 13;11(9):1674. doi: 10.3390/diagnostics11091674.
PubMed 34574015Johnson 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.
PubMed 36815099Bignardi 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.
PubMed 36564223Srivastava 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 29132945Galan 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.
PubMed 28869042Hung 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.
PubMed 35141237Alqahtani 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.
PubMed 35516683Echouffo-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.
PubMed 26997583Basnet TB, Du S, Feng R, Gao J, Gong J, Ye W. Fatty liver mediates the association of hyperuricemia with prediabetes and diabetes: a weighting-based mediation analysis. Front Endocrinol (Lausanne). 2023 Apr 12;14:1133515. doi: 10.3389/fendo.2023.1133515. eCollection 2023.
PubMed 37124731
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperuricemia as a Predictor of Chronic Kidney Disease (CKD) Progression in Prediabetic Patients
- ClinicalTrials.gov ID
- NCT07199205
- Acronym / sponsor ID
- CKD progression in prediabetic
- Conditions
- CKD Progression
- Keywords
- CKD, Prediabetes, Hyperuricemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Chronic kidney disease (CKD) is a global health concern, characterized by a gradual loss of kidney function, and is associated with increased morbidity and mortality. Hyperuricemia, defined as elevated serum uric acid levels, has been identified as both a consequence and a potential contributor to CKD progression. Recent studies have shown that hyperuricemia can aggravate renal impairment through mechanisms such as direct nephrotoxicity, activation of the inflammasome, increased oxidative stress, and endothelial dysfunction.
Epidemiological evidence indicates that hyperuricemia often precedes the development of CKD and may serve as an independent predictor of its onset and progression, even after adjusting for traditional risk factors like hypertension, proteinuria, and dyslipidemia. The prevalence of hyperuricemia is notably higher among CKD patients, reaching up to 38% in some populations. Furthermore, hyperuricemia is implicated in the pathogenesis of several metabolic disorders, including hypertension, obesity, and metabolic syndrome, all of which are risk factors for CKD.
Prediabetes, a state of impaired glucose metabolism, is increasingly recognized as a risk factor for both cardiovascular disease and CKD. Studies have found that individuals with prediabetes exhibit higher serum uric acid levels compared to normoglycemic individuals, and that elevated uric acid is associated with increased risk of progression to diabetes and CKD. The relationship between hyperuricemia and prediabetes appears to be mediated by factors such as fatty liver, dyslipidemia, and body mass index, highlighting the complex interplay between metabolic health and kidney function.
Clinical research has demonstrated that higher serum uric acid levels are associated with a more rapid decline in estimated glomerular filtration rate (eGFR) and an increased risk of progression to end-stage renal disease (ESRD). For example, a baseline uric acid level of ≥7.5 mg/dL has been shown to significantly increase the risk of renal function decline in hypertensive and non-diabetic populations. Additionally, the serum uric acid to high-density lipoprotein (HDL) cholesterol ratio has emerged as a novel marker for predicting CKD risk, reflecting the balance between pro-inflammatory and anti-inflammatory processes.
Despite these associations, the causality of hyperuricemia in CKD progression remains a topic of debate, as some clinical trials have yielded conflicting results regarding the benefits of uric acid-lowering therapy in slowing CKD progression. However, recent genetic and epidemiological studies suggest that hyperuricemia represents a significant risk factor for CKD, independent of genetic predisposition and other comorbidities. The mechanisms by which uric acid may induce kidney injury include crystal deposition, oxidative stress, activation of the renin-angiotensin-aldosterone system, and impairment of endothelial function.The burden of CKD in prediabetic individuals is of particular concern, as early identification of modifiable risk factors such as hyperuricemia could facilitate timely interventions to prevent or delay CKD progression. Given the increasing prevalence of both prediabetes and hyperuricemia worldwide, understanding their interplay is crucial for developing effective preventive strategies.
Despite growing evidence linking hyperuricemia to CKD progression, particularly in at-risk populations such as prediabetic patients, the predictive value of elevated serum uric acid for CKD progression in this group remains underexplored. This study aims to clarify whether hyperuricemia can serve as an early and independent predictor of CKD progression in prediabetic patients, thereby informing clinical practice and guiding risk stratification and management in this vulnerable population
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CKD progression in prediabetics
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 34574015Lee TH, Chen JJ, Wu CY, Yang CW, Yang HY. Hyperuricemia and Progression of Chronic Kidney Disease: A Review from Physiology and Pathogenesis to the Role of Urate-Lowering Therapy. Diagnostics (Basel). 2021 Sep 13;11(9):1674. doi: 10.3390/diagnostics11091674.
- Background: PubMed 36815099Johnson 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.
- Background: PubMed 36564223Bignardi 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.
- Background: PubMed 29132945Srivastava 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.
- Background: PubMed 28869042Galan 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.
- Background: PubMed 35141237Hung 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.
- Background: PubMed 35516683Alqahtani 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.
- Background: PubMed 26997583Echouffo-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.
- Background: PubMed 37124731Basnet TB, Du S, Feng R, Gao J, Gong J, Ye W. Fatty liver mediates the association of hyperuricemia with prediabetes and diabetes: a weighting-based mediation analysis. Front Endocrinol (Lausanne). 2023 Apr 12;14:1133515. doi: 10.3389/fendo.2023.1133515. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD Progression, run by Assiut University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CKD progression in prediabetics (time frame: 1 year). 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 NCT07199205, which also lists 9 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 30 Sep 2025.