Chronic Kidney DiseasesNCT07803237
Predictors of Rapid CKD Progression
An observational study of Chronic Kidney Diseases and Kidney Failure, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Kidney Failure, Chronic Renal Insufficiency
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2028
- How long will I take part?
- 24 Months
- 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
- Adult, Older adult
Study population: Adult patients with predialysis chronic kidney disease (CKD) attending the Nephrology outpatient clinic and inpatient ward at Assiut University Hospitals.
Who may be able to join
- 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
Who cannot join
- Acute kidney injury
- Current maintenance dialysis
- Previous kidney transplantation
- Active malignancy
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictors of Rapid Progression of Chronic Kidney Disease in Predialysis Patients: A Single-Center Prospective Study in Assiut University Hospitals
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
Read the detailed description
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.
- Conditions
- Chronic Kidney Diseases, Kidney Failure, Chronic Renal Insufficiency, CKD, Kidney Failure, Chronic
- Keywords
- Chronic Kidney Disease, CKD, Predictors; Predialysis; eGFR
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency, Kidney Failure, Chronic
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 |
|---|---|---|
| Predialysis CKD Patients | Adult patients with chronic kidney disease not receiving maintenance dialysis, followed prospectively for 24 months to assess rapid disease progression. This is an observational study with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of rapid CKD progression
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.
Measured: 24 months
Secondary outcomes (3)
Independent predictors of rapid CKD progression
Clinical and laboratory variables independently associated with rapid CKD progression using multivariate logistic regression analysis.
Measured: 24 months
Change in estimated glomerular filtration rate (eGFR)
Absolute change in eGFR (mL/min/1.73 m²) from baseline to follow-up visits.
Measured: Baseline, 12 months, and 24 months
Change in albuminuria
Change in urine albumin-to-creatinine ratio from baseline to follow-up visits.
Measured: Baseline, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Dahi Mohamed, Assiut University
- Investigators
- Effat A tony, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803237
- Sponsor's protocol ID
- CKD-RapidProg-2026
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali I, Chinnadurai R, Ibrahim ST, Green D, Kalra PA. Predictive factors of rapid linear renal progression and mortality in patients with chronic kidney disease. BMC Nephrol. 2020 Aug 14;21(1):345. doi: 10.1186/s12882-020-01982-8.
PubMed 32795261Lee FY, Islahudin F, Ali Nasiruddin AY, Abdul Gafor AH, Wong HS, Bavanandan S, Mohd Saffian S, Md Redzuan A, Mohd Tahir NA, Makmor-Bakry M. Effects of CYP3A5 Polymorphism on Rapid Progression of Chronic Kidney Disease: A Prospective, Multicentre Study. J Pers Med. 2021 Mar 30;11(4):252. doi: 10.3390/jpm11040252.
PubMed 33808503Inaguma D, Hayashi H, Yanagiya R, Koseki A, Iwamori T, Kudo M, Fukuma S, Yuzawa Y. Development of a machine learning-based prediction model for extremely rapid decline in estimated glomerular filtration rate in patients with chronic kidney disease: a retrospective cohort study using a large data set from a hospital in Japan. BMJ Open. 2022 Jun 9;12(6):e058833. doi: 10.1136/bmjopen-2021-058833.
PubMed 35680264
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Rapid Progression of Chronic Kidney Disease in Predialysis Patients: A Single-Center Prospective Study in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT07803237
- Acronym / sponsor ID
- CKD-RapidProg-2026
- Conditions
- Chronic Kidney Diseases, Kidney Failure, Chronic Renal Insufficiency, CKD, Kidney Failure, Chronic
- Keywords
- Chronic Kidney Disease, CKD, Predictors; Predialysis; eGFR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 Sep 2026 (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.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Predialysis CKD Patients | – | –Adult patients with chronic kidney disease not receiving maintenance dialysis, followed prospectively for 24 months to assess rapid disease progression. This is an observational study with no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with predialysis chronic kidney disease (CKD) attending the Nephrology outpatient clinic and inpatient ward at Assiut University Hospitals.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Acute kidney injury
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
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.
3 secondary outcomes
Independent predictors of rapid CKD progression
Time frame: 24 months
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline, 12 months, and 24 months
Change in albuminuria
Time frame: Baseline, 12 months, and 24 months
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 3 Sep 2026.
- Background: PubMed 32795261Ali I, Chinnadurai R, Ibrahim ST, Green D, Kalra PA. Predictive factors of rapid linear renal progression and mortality in patients with chronic kidney disease. BMC Nephrol. 2020 Aug 14;21(1):345. doi: 10.1186/s12882-020-01982-8.
- Background: PubMed 33808503Lee FY, Islahudin F, Ali Nasiruddin AY, Abdul Gafor AH, Wong HS, Bavanandan S, Mohd Saffian S, Md Redzuan A, Mohd Tahir NA, Makmor-Bakry M. Effects of CYP3A5 Polymorphism on Rapid Progression of Chronic Kidney Disease: A Prospective, Multicentre Study. J Pers Med. 2021 Mar 30;11(4):252. doi: 10.3390/jpm11040252.
- Background: PubMed 35680264Inaguma D, Hayashi H, Yanagiya R, Koseki A, Iwamori T, Kudo M, Fukuma S, Yuzawa Y. Development of a machine learning-based prediction model for extremely rapid decline in estimated glomerular filtration rate in patients with chronic kidney disease: a retrospective cohort study using a large data set from a hospital in Japan. BMJ Open. 2022 Jun 9;12(6):e058833. doi: 10.1136/bmjopen-2021-058833.
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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.
Effat A tony, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Kidney Failure, 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 5 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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?
Contact Noura D Fahmi, Resident (01225407990, Nura.18313461@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of rapid CKD progression (time frame: 24 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 NCT07803237, which also lists 3 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 3 Sep 2026.