Anemia Correction and Fibroblast Growth Factor 23 Levels in Chronic Kidney Disease , and Renal Transplant Patient

Endothelial Dysfunction Clinical Trial

Official title:

Impact of Anemia Correction and Fibroblast Growth Factor 23 Levels in Left Ventricular Hypertrophy, and Early Endothelial Dysfunction in Chronic Kidney Disease, and Renal Transplant Patient

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03193073
• Other study ID #: 17200031
• Status: Suspended
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The fibroblast growth factor-23-bone-kidney axis is part of newly discovered biological systems linking bone to other organ functions through a complex endocrine network that is integrated with the parathormone/vitamin D axis and which plays an equally important role in health and disease . Most of the known physiological function of fibroblast growth factor 23 to regulate mineral metabolism can be accounted for by actions of this hormone on the kidney.In a recent experimental study, fibroblast growth factor-23 was shown to cause pathological hypertrophy in rat cardiomyocytes by "calcineurin-nuclear factor of activated T cells" and treatment with fibroblast growth factor -blockers reduced left ventricular hypertrophy in experimental models of chronic renal failure.The current hypothesis is that, in healthy individuals, iron deficiency stimulates increased production of fibroblast growth factor23. At the same time, iron is thought to be the cofactor of enzymes taking part in the degradation of intact fibroblast growth factor-23 and thought to have a role in the excretion of degraded FGF-23 parts .Studies speculated that Angiotensin Converting Enzyme inhibitors may exert their anti-proteinuria effects at least in part by reducing serum fibroblast growth factor-23 levels although it is difficult from the results of this study to understand which comes first and brings about the other; decrease in proteinuria or fibroblast growth factor-23. Available evidence points to the deleterious effects of increased fibroblast growth factor-23 level in proteinuria, but the precise molecular mechanism still remains to be explored. An intricate and close association exists among parathormone, phosphorus, active vitamin D with FGF23, but the independent role of the latter on proteinuria is the least explored. Elaborately conducted studies that control effects of confounding factors adequately are needed to demonstrate the independent pathogenic role of FGF23.

Description:

1. To study the effect of anemia correction and left ventricular hypertrophy in Chronic Kidney Disease patients and renal transplant patients .

2. To study the relation of fibroblast growth factor and Left ventricular hypertrophy in Chronic kidney disease and renal transplant patients.

3. To study the relation between fibroblast growth factor 23 and early endothelial dysfunction in both Chronic kidney disease and renal transplant patients.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

All patients:

1. Above 18 years old

2. Diagnosed as CKD, and renal transplanted patients at Assiut University Hospital in the period 2017-2020 .

Exclusion Criteria:

1. Severely hypocalcaemic patients < 7mg/dl.

2. Severely hyperphosphatemic patients >7 mg/dl .

3. Uncontrolled hypertensive patients ( more than 3 antihypertensive drugs).

4. Uncontrolled diabetic patients HBA1C >8 .

5. Blood transfusion dependent

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Kidney Disease
• Endothelial Dysfunction
• Fibroblast Growth Factor 23
• Hypertrophy
• Hypertrophy, Left Ventricular
• Kidney Diseases
• Left Ventricular Hypertrophy
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• detailed echocardiography
Detailed Echocardiography including ejection fraction, interventricular septum thickness, posterior wall thickness, left ventricular end -diastolic and end- systolic diameter and left ventricular mass index will be correlated with body surface area for both groups serum FGF-23
• serum fibroblast growth factor-23
serum levels of FGF-23
• flow mediated dilatation of forearm
superficial sonar assess the diameter of brachial vessel on exposure to stress

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Omnia Mohammed Hashem

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Eser B, Yayar O, Buyukbakkal M, Erdogan B, Ercan Z, Merhametsiz O, Haspulat A, Oguz EG, Dogan I, Canbakan B, Ayli MD. Fibroblast growth factor is associated to left ventricular mass index, anemia and low values of transferrin saturation. Nefrologia. 2015; — View Citation

Grabner A, Amaral AP, Schramm K, Singh S, Sloan A, Yanucil C, Li J, Shehadeh LA, Hare JM, David V, Martin A, Fornoni A, Di Marco GS, Kentrup D, Reuter S, Mayer AB, Pavenstädt H, Stypmann J, Kuhn C, Hille S, Frey N, Leifheit-Nestler M, Richter B, Haffner D — View Citation

Io H, Aizawa M, Funabiki K, Horikoshi S, Tomino Y. Impact of anaemia treatment for left ventricular remodelling prior to initiation of dialysis in chronic kidney disease patients: Efficacy and stability of long acting erythropoietin stimulating agents. Ne — View Citation

Torun D, Yildiz I, Micozkadioglu H, Nursal GN, Yigit F, Ozelsancak R. The effects of cinacalcet treatment on bone mineral metabolism, anemia parameters, left ventricular mass index and parathyroid gland volume in hemodialysis patients with severe secondar — View Citation

Wolf M, Koch TA, Bregman DB. Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women. J Bone Miner Res. 2013 Aug;28(8):1793-803. doi: 10.1002/jbmr.1923. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	if change of in Hemoglobin level and correction of anemia associated with change in the left ventricular outcomes	measure the left ventricular mass index (gm/m2)	measures at time of diagnosis then after 3 months
Primary	the relationship between the FGF-23 and degree of left ventricular dysfunction	measure FGF-23 level in (pg/ml)	measure at time of diagnosis
Primary	the relationship between FGF-23 level and early endothelial dysfunction	change in arterial diameter in mm	at time of diagnosis in chronic kidney disease / after 6 months in renal transplant