Cardiovascular Diseases Clinical Trial
— OPERA-CKDOfficial title:
An Observational, Open-label Pilot Study to Evaluate the Effect of Standard-of-care Erythropoiesis-stimulating Agents (Darbepoetin Alfa) on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease.
Verified date | February 2024 |
Source | Cambridge University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | May 21, 2018 |
Est. primary completion date | May 21, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria CKD patients: - Provided written informed consent to participate - Be aged 18 years or over - Clinically suitable for EPO (Darbepoetin) therapy as part of routine NHS standard of care for anaemia due to chronic kidney disease (CKD) - No prior EPO treatment within the preceding 12 months - Palpable brachial artery Inclusion Criteria Healthy Volunteers: - Provided written informed consent to participate - Aged 18 years or over - Blood pressure <140/90 - Normal haematology and renal function (defined as a normal creatinine and eGFR measured at any time in the last 6 months or at screening) - Not on any regular prescribed medication - Palpable brachial artery Exclusion criteria CKD patients: - Kidney transplant: Planned living-related kidney transplant within 26 weeks - Patients on PDE5 inhibitors, alpha blockers, or nitrates (other than PRN GTN), unless they can be omitted until after the forearm study on the day of the visit - MI or acute coronary syndrome in the preceding = 4 weeks prior to screening - Stroke or transient ischemic attack in the preceding = 4 weeks prior to screening - Known clinical diagnosis of Heart failure: NYHA Class III-IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system. - Clinic Blood pressure: sustained BP > 170/100 mm Hg (on repeated measurements) - Pregnancy - Non-sterilised, pre-menopausal women will undergo urinary beta-HCG testing at every visit and be given advice on contraceptive use in the PIS. - Any other reason for exclusion from this study in the opinion of the Principal Investigator Exclusion Criteria Healthy Volunteers: - Any condition which, in the opinion of the investigator, precludes enrolment - Undergoing investigation for any serious medical condition |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrooke's Hospital | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust | GlaxoSmithKline |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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