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

June 25, 2018 updated by: Omnia Mohammed Hashem

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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 .
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
Diagnostic test: serum fibroblast growth factor-23
serum levels of FGF-23
Diagnostic test: flow mediated dilatation of forearm
superficial sonar assess the diameter of brachial vessel on exposure to stress
ACTIVE_COMPARATOR: 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
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
Diagnostic test: serum fibroblast growth factor-23
serum levels of FGF-23
Diagnostic test: flow mediated dilatation of forearm
superficial sonar assess the diameter of brachial vessel on exposure to stress

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omnia Mohammed Hashem

Investigators

  • Study Director: Mohammed Ali Tohamy, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (ACTUAL)

June 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia of Chronic Kidney Disease

Clinical Trials on detailed echocardiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe