AzTrials
AzTrials

CKDNCT05691985

Fib to Alb Ratio in Type 2 Dkd

An observational study of CKD and Type 2 Diabetes, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aimed to investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2 and to prove its possible role as a novel biomarker to predict and prevent DKD progression. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
CKD, Type 2 Diabetes
How many people
50 participants
Where
1 siteEgypt
Study dates
25 Jul 2024to 15 Oct 2025
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • Adult, Older adult

Study population: Patients are selected on criteria of all genders, age above 18, type 2 DM and CKD. Patients are selected from clinics, community and pts admitted at hospital.

Who may be able to join

  • Age above 18 yrs.
  • 50 Pts with type 2 DM that have DKD (presence of albuminuria in association with diabetic retinopathy) and 50 pts with type 2 DM but have no DKD.

Who cannot join

  • Age below 18 yrs.
  • Pts with ESKD, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with DKA and Cancer.
  • Pt who refused to contribute in this study

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of medicine Assiut university

    Asyut, 71515

Other trials in Egypt

About this study

Official title: Fibrinogen to Albumin Ratio (FAR) as a Risk Factor for Type 2 Diabetic Nephropathy(DN)

Aimed to investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2 and to prove its possible role as a novel biomarker to predict and prevent DKD progression.

Read the detailed description

Diabetic kidney disease (DKD) is the most prevalent chronic kidney disease. Around 3540% of patients with type 2 diabetes mellitus (T2DM) will go on to develop DKD. DKD is characterized by albuminuria and reduced estimated glomerular filtration rate (eGFR), both of which are independent risk factors for end-stage kidney disease (ESKD), cardiovascular events, and death. DKD accounts for a significant increase in mortality among diabetic patients and is a grave threat to their clinical outcome.

Inflammation plays a major role in the development of DKD. Serum fibrinogen (FIB) is a biomarker of coagulation and inflammation. Elevated serum FIB is an independent risk factor of DKD progression to ESKD in patients with T2DM. Albumin (ALB) has anti-inflammatory functions and antioxidant properties. Hypoalbuminemia is associated with a poorer renal prognosis in patients with T2DM and DKD. Fibrinogen to albumin ratio (FAR) is a more significant prognostic marker than each single marker itself in cancer study.

Conditions
CKD, Type 2 Diabetes
Medical subject headings
Diabetes Mellitus, Type 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The association of fibrinogen to albumin ratio (FAR) with DKD type 2.

    investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study start25 Jul 2024
  3. Primary completion12 Mar 2025
  4. Study completion15 Oct 2025

Resources

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
50 participants (actual)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05691985
Sponsor's protocol ID
Fib to Alb ratio
Status last verified
Sep 2026
First submitted
11 Jan 2023
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Perez-Morales RE, Del Pino MD, Valdivielso JM, Ortiz A, Mora-Fernandez C, Navarro-Gonzalez JF. Inflammation in Diabetic Kidney Disease. Nephron. 2019;143(1):12-16. doi: 10.1159/000493278. Epub 2018 Oct 1.

    PubMed 30273931

  • GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.

    PubMed 32061315

  • Martinez-Castelao A, Navarro-Gonzalez JF, Gorriz JL, de Alvaro F. The Concept and the Epidemiology of Diabetic Nephropathy Have Changed in Recent Years. J Clin Med. 2015 May 28;4(6):1207-16. doi: 10.3390/jcm4061207.

    PubMed 26239554

  • Berhane AM, Weil EJ, Knowler WC, Nelson RG, Hanson RL. Albuminuria and estimated glomerular filtration rate as predictors of diabetic end-stage renal disease and death. Clin J Am Soc Nephrol. 2011 Oct;6(10):2444-51. doi: 10.2215/CJN.00580111. Epub 2011 Aug 18.

    PubMed 21852671

  • Luyendyk JP, Schoenecker JG, Flick MJ. The multifaceted role of fibrinogen in tissue injury and inflammation. Blood. 2019 Feb 7;133(6):511-520. doi: 10.1182/blood-2018-07-818211. Epub 2018 Dec 6.

    PubMed 30523120

  • Hsieh JY, Smith TD, Meli VS, Tran TN, Botvinick EL, Liu WF. Differential regulation of macrophage inflammatory activation by fibrin and fibrinogen. Acta Biomater. 2017 Jan 1;47:14-24. doi: 10.1016/j.actbio.2016.09.024. Epub 2016 Sep 20.

    PubMed 27662809

  • Zhang J, Wang Y, Zhang R, Li H, Han Q, Wu Y, Wang S, Guo R, Wang T, Li L, Liu F. Serum fibrinogen predicts diabetic ESRD in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2018 Jul;141:1-9. doi: 10.1016/j.diabres.2018.04.025. Epub 2018 Apr 21.

    PubMed 29684616

  • Zhang J, Zhang R, Wang Y, Li H, Han Q, Wu Y, Wang T, Liu F. The Level of Serum Albumin Is Associated with Renal Prognosis in Patients with Diabetic Nephropathy. J Diabetes Res. 2019 Feb 17;2019:7825804. doi: 10.1155/2019/7825804. eCollection 2019.

    PubMed 30911552

  • American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S13-S27. doi: 10.2337/dc18-S002.

    PubMed 29222373

  • KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.

    PubMed 17276798

  • Sorensen I, Susnik N, Inhester T, Degen JL, Melk A, Haller H, Schmitt R. Fibrinogen, acting as a mitogen for tubulointerstitial fibroblasts, promotes renal fibrosis. Kidney Int. 2011 Nov;80(10):1035-44. doi: 10.1038/ki.2011.214. Epub 2011 Jul 6.

    PubMed 21734641

  • Myrup B, de Maat M, Rossing P, Gram J, Kluft C, Jespersen J. Elevated fibrinogen and the relation to acute phase response in diabetic nephropathy. Thromb Res. 1996 Feb 15;81(4):485-90. doi: 10.1016/0049-3848(96)00021-7.

    PubMed 8907298

  • Pan L, Ye Y, Wo M, Bao D, Zhu F, Cheng M, Ni X, Fei X. Clinical Significance of Hemostatic Parameters in the Prediction for Type 2 Diabetes Mellitus and Diabetic Nephropathy. Dis Markers. 2018 Feb 4;2018:5214376. doi: 10.1155/2018/5214376. eCollection 2018.

    PubMed 29511389

  • Tessari P, Kiwanuka E, Barazzoni R, Vettore M, Zanetti M. Diabetic nephropathy is associated with increased albumin and fibrinogen production in patients with type 2 diabetes. Diabetologia. 2006 Aug;49(8):1955-61. doi: 10.1007/s00125-006-0288-2. Epub 2006 May 16.

    PubMed 16703327

  • Erdogan G, Arslan U, Yenercag M, Durmus G, Tugrul S, Sahin I. Relationship Between the Fibrinogen-to-Albumin Ratio and SYNTAX Score in Patients with Non-St-Elevation Myocardial Infarction. Rev Invest Clin. 2021 Feb 3;73(3):182-189. doi: 10.24875/RIC.20000534.

    PubMed 33535227

Questions about this trial

What is this clinical trial studying?

An observational study of CKD and Type 2 Diabetes, run by Assiut University at 1 site in Egypt.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The association of fibrinogen to albumin ratio (FAR) with DKD type 2. (time frame: baseline). 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 NCT05691985, which also lists 15 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 9 Sep 2026.

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