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Evaluating the Effect of Standard-of-care Erythropoiesis-stimulating Agents on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease.

NCT02987465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2024-02-07

No results posted yet for this study

Summary

In people diagnosed with chronic kidney disease (CKD) anaemia is a common problem and is often treated with EPO (Erythropoietin). One form of EPO used is Darbepoetin (Aranesp®). EPO is safe to use but it has been associated with a rise in blood pressure (BP) in some individuals. The reasons for this are not clear. To try to explain this, this study will look at how EPO affects certain substances in the blood that influence how blood vessels contract and relax. This will be conducted by infusing small amounts of Acetylcholine, BQ123 and Noradrenaline into the arm vessels of volunteers using an established method called Forearm blood flow (plethysmography). Volunteers recruited for this study will include CKD patients undergoing therapy with Darbepoetin as part of their normal NHS care as well as healthy people not on treatment, who will act as controls. This is an observational pilot study of changes in physiology before and after Darbepoetin. It will provide valuable data for a later study comparing Darbepoetin to novel agents which work via different pathways to treat anaemia.

Conditions

Interventions

DRUG

Darbepoetin Alfa

Darbepoetin is not a study drug and is prescribed as part of routine treatment of anaemia in CKD1. Darbepoetin is licensed for use for the treatment of anaemia in the context of CKD. It will be provided as part of the standard clinical care of the renal patients in this study. Healthy Volunteers will not be treated with Darbepoetin.

DRUG

Acetylcholine

Acetylcholine is being used as a challenge agent in this study and assesses NO-mediated vasodilation

DRUG

Noradrenaline

Noradrenaline is being used as a challenge agent in this study and is an endogenous a1 adrenoceptor agonist

DRUG

BQ 123

BQ 123 is being used as a challenge agent in this study and is an (Endothelin A) ETA receptor agonist.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Joseph Cheriyan, MBCHB, MA, FRCP · Cambridge University Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-20
Primary Completion
2018-05-21
Completion
2018-05-21

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02987465 on ClinicalTrials.gov