Anemia Correction and Fibroblast Growth Factor 23 Levels in Chronic Kidney Disease , and Renal Transplant Patient
NCT ID: NCT03193073
Last Updated: 2018-06-27
Study Results
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Basic Information
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SUSPENDED
NA
80 participants
INTERVENTIONAL
2018-09-01
2020-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Also assesment of FGF-23 in different stages of group A, assessment of FGF-23 before and after renal transplant
DIAGNOSTIC
NONE
Study Groups
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CKD patients with different stages
1. Full clinical history and through clinical examination.
2. Full blood count at time of diagnosis and 3 months after initiation of treatment with iron and erythropoietin Stimulating agents.
3. Iron study at time of diagnosis and 3 months after treatment .
4. Serum calcium , phosphorus, intact Parathrmone hormone. 5-24- urinary proteins or Albumin Creatinine ratio every month (for 3 months )then every 3 months (1 st year), then annually.
6- Lipid profile . 7-Estimated glomerular filtration rate by MDRD equation .
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
Newly renal transplanted patients .
1. Full clinical history and through clinical examination.
2. Pre transplant Serum calcium , phosphorus , I Parathrmone hormone , serial measures every / 3 months for 2 years.
3. Pre-transplant full blood count serial measures every / 3 months for 2 years.
4. Pre transplant serum Iron study and annually for 2 years.
5. 24- urinary proteins or albumin-creatinine ratio every month (for 3 months )then every 3 months (1 st year), then annually.
6. Post-transplant serum FGF-23 (as independent risk factor) at 6months.
7. Different immunosuppressive protocols.
8. Pre-transplant panel reactive antibody,donor-specific antibody
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
1. Above 18 years old
2. Diagnosed as CKD, and renal transplanted patients at Assiut University Hospital in the period 2017-2020 .
Exclusion Criteria
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
18 Years
60 Years
ALL
No
Sponsors
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Omnia Mohammed Hashem
OTHER
Responsible Party
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Omnia Mohammed Hashem
Assistant lecturer at Assiuy university- faculty of medicine-internal medicine department
Principal Investigators
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Mohammed Ali Tohamy, professor
Role: STUDY_DIRECTOR
Assiut University
Locations
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Assiut University Hospitals
Asyut, , Egypt
Countries
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References
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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, Pavenstadt H, Stypmann J, Kuhn C, Hille S, Frey N, Leifheit-Nestler M, Richter B, Haffner D, Abraham R, Bange J, Sperl B, Ullrich A, Brand M, Wolf M, Faul C. Activation of Cardiac Fibroblast Growth Factor Receptor 4 Causes Left Ventricular Hypertrophy. Cell Metab. 2015 Dec 1;22(6):1020-32. doi: 10.1016/j.cmet.2015.09.002. Epub 2015 Oct 1.
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 secondary hyperparathyroidism. Saudi J Kidney Dis Transpl. 2016 Jan;27(1):15-22. doi: 10.4103/1319-2442.174053.
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.
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;35(5):465-72. doi: 10.1016/j.nefro.2015.06.025. Epub 2015 Sep 26. English, Spanish.
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. Nephrology (Carlton). 2015 Dec;20 Suppl 4:7-13. doi: 10.1111/nep.12640.
Other Identifiers
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17200031
Identifier Type: -
Identifier Source: org_study_id
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