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NCT Number: NCT07803237

Predictors of Rapid CKD Progression

This prospective observational cohort study aims to identify independent predictors of rapid chronic kidney disease (CKD) progression and determine its incidence among predialysis CKD patients. A total of 190 adult patients will be enrolled from the nephrology outpatient clinic and inpatient ward at Assiut University Hospitals and followed for 24 months. Rapid progression is defined as a sustained decline in eGFR > 5 mL/min/1.73 m² per year according to KDIGO 2024 criteria. Clinical and laboratory parameters will be assessed at baseline and during follow-up to identify predictive factors

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Key information

Conditions

Chronic Kidney Diseases CKD Chronic Disease Chronic Renal Insufficiency Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Chronic kidney disease (CKD) is a major global public health problem affecting approximately 10% of the population worldwide. Diabetes mellitus and hypertension remain the leading causes of CKD, accounting for the majority of patients progressing to kidney failure.

The clinical course of CKD is highly heterogeneous. While some patients maintain stable kidney function, others experience rapid deterioration leading to kidney failure within a relatively short period. Rapid progression of CKD is associated with a markedly increased risk of kidney failure, cardiovascular events, and all-cause mortality.

According to KDIGO 2024 guidelines, a sustained decline in eGFR exceeding 5 mL/min/1.73 m² per year is considered rapid progression and warrants careful evaluation and optimization of renoprotective therapy. Early identification of patients at risk of rapid progression enables clinicians to intensify monitoring, initiate renoprotective therapies, and prepare patients appropriately for kidney replacement therapy.

This prospective cohort study will enroll 190 adult patients with predialysis CKD from the nephrology outpatient clinic and inpatient ward at Assiut University Hospitals. Participants will undergo comprehensive clinical and laboratory assessment at baseline, including demographic data, comorbidities, eGFR (CKD-EPI equation), complete blood count, liver function tests, electrolytes, uric acid, bicarbonate, CRP, lipid profile, and thyroid function tests. Patients will be followed for 24 months to assess the incidence of rapid progression and identify independent predictors using multivariable regression analysis.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Diagnosis of CKD according to KDIGO 2024 criteria
  • Predialysis status (not on maintenance dialysis)
  • Ability to provide written informed consent
  • Availability for 24-month follow-up

Exclusion criteria

  • Acute kidney injury
  • Current maintenance dialysis
  • Previous kidney transplantation
  • Active malignancy
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Incidence of rapid CKD progression

    Time frame: 24 months

    Proportion of participants who experience rapid CKD progression, defined as a sustained decline in eGFR greater than 5 mL/min/1.73 m² per year.

Secondary outcomes

  1. Independent predictors of rapid CKD progression

    Time frame: 24 months

    Clinical and laboratory variables independently associated with rapid CKD progression using multivariate logistic regression analysis.

  2. Change in estimated glomerular filtration rate (eGFR)

    Time frame: Baseline, 12 months, and 24 months

    Absolute change in eGFR (mL/min/1.73 m²) from baseline to follow-up visits.

  3. Change in albuminuria

    Time frame: Baseline, 12 months, and 24 months

    Change in urine albumin-to-creatinine ratio from baseline to follow-up visits.

Study contacts

Contact information is provided by the study sponsor or research team.

Noura D Fahmi, Resident

CONTACT

[email protected]

01225407990

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Predictors of Rapid Progression of Chronic Kidney Disease in Predialysis Patients: A Single-Center Prospective Study in Assiut University Hospitals

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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