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Clinical Trial Details

Trial ID: L0485
Source ID: NCT02987465
Associated Drug: Darbepoetin Alfa
Title: 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.
Acronym: OPERA-CKD
Status: COMPLETED
Study Results: NO
Results:
Conditions: Cardiovascular Diseases|Chronic Kidney Disease
Interventions: DRUG: Darbepoetin Alfa|DRUG: Acetylcholine|DRUG: Noradrenaline|DRUG: BQ 123
Outcome Measures: Primary: Response to intra-arterial acetylcholine, Change in forearm blood flow responses as measured by venous occlusion plethysmography, in response to intra-arterial acetylcholine, CKD patients: Measured at baseline and at the end of the 6 week treatment period | Secondary: Response to intra-arterial Noradrenaline, Change in forearm blood flow responses, as measured by venous occlusion plethysmography, in response to intra-arterial Noradrenaline, CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin|Response to intra-arterial BQ123, Change in forearm blood flow responses as measured by venous occlusion plethysmography, in response to intra-arterial BQ123, CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin|Change in mean arterial blood pressure, Change in mean arterial blood pressure, systolic blood pressure and diastolic blood pressure post-Darbepoetin-Alfa over 6 weeks of treatment, CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin|Changes in Arterial stiffness, Changes in arterial stiffness post-darbepoetin-alfa, CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin|Correlations between individual challenge agent, Correlations between individual challenge agent forearm blood flow responses and change in blood pressure, CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin|Forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with CKD compared to healthy volunteers, Change in forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with anaemia associated with CKD at baseline compared to healthy volunteers, Healthy Volunteers: Measured at baseline; CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin|Responses to Acetylcholine, Noradrenaline and BQ123 in patients with CKD post-Darbepoetin compared to healthy volunteers, Change in forearm blood flow responses to Acetylcholine, Noradrenaline and BQ123 in patients with anaemia associated with CKD post-Darbepoetin compared to healthy volunteers, Healthy Volunteers: Measured at baseline; CKD patients: Measured at baseline before treatment with Darbepoetin and then at the end of the 6 week treatment period with Darbepoetin
Sponsor/Collaborators: Sponsor: Cambridge University Hospitals NHS Foundation Trust | Collaborators: GlaxoSmithKline
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 29
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2017-02-20
Completion Date: 2018-05-21
Results First Posted:
Last Update Posted: 2024-02-07
Locations: Addenbrooke's Hospital, Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02987465