ClinicalTrials.gg
Not yet recruitingNCT07803237Updated Sep 3, 2026

Predictors of Rapid CKD Progression

An observational study in Chronic Kidney Diseases, Kidney Failure and Chronic Renal Insufficiency, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Primary conditionKidney Failure, ChronicRegistry: Renal Insufficiency, ChronicReclassifiedWhy we changed it
Registry
Renal Insufficiency, Chronic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Kidney Failure, Chronic
Why
  1. The study's listed conditions name Kidney Failure, Chronic, a narrower term within Renal Insufficiency, Chronic.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
190
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Chronic Kidney Diseases
  • Kidney Failure
  • Chronic Renal Insufficiency
  • CKD
  • Kidney Failure, Chronic

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Keywords

  • Chronic Kidney Disease
  • CKD
  • Predictors; Predialysis; eGFR
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In context

Kidney Failure, Chronic Reclassified

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's planned enrollment of 190 is above the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency, Chronic. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patients with predialysis chronic kidney disease (CKD) attending the Nephrology outpatient clinic and inpatient ward at Assiut University Hospitals.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Availability for 24-month follow-up

Exclusion criteria

Exclusion Criteria:

  • Acute kidney injury

    • Current maintenance dialysis
    • Previous kidney transplantation
    • Active
    • Pregnancy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
190 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

Secondary outcomes

  1. Independent predictors of rapid CKD progression

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

    Time frame: 24 months

  2. Change in estimated glomerular filtration rate (eGFR)

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

    Time frame: Baseline, 12 months, and 24 months

  3. Change in albuminuria

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

    Time frame: Baseline, 12 months, and 24 months

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Study locations

No study locations are listed for this record.

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References and documents

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 32795261 ↗
  • Lee 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 33808503 ↗
  • Inaguma 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 131 non-industry observational studies under Kidney Failure, Chronic, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's planned 12 months is below that.

Counting every sponsor, half of 150 studies reached it within 29 months; a quarter within 11 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 3, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Mar 1, 2028
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07803237
Lead sponsor
Assiut University
Responsible party
Noura Dahi Mohamed (Resident Physician department of internal medicine, Assiut University) — Principal investigator
First posted
Sep 3, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Sep 3, 2026

Study contacts

Noura D Fahmi, Resident
Contact
Nura.18313461@med.aun.edu.eg
01225407990
Effat A tony, prof
study chair · Internal Medicine Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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