Establishing the benefits of a tablet commonly used to treat raised blood pressure in people with Chronic Kidney Disease stage 3b.

Conditions: We plan a large pragmatic trial to test the potential for spironolactone to to reduce overall cardiovascular events and death, to delay the decline in renal function, and to improve surrogate markers for vascular disease in people with stage 3b (eGFR 30-44 ml/min/1.73m2)Chronic Kidney Disease.
MedDRA version: 15.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857
MedDRA version: 15.1Level: PTClassification code 10018355Term: Glomerular filtration rateSystem Organ Class: 10022891 - Investigations
MedDRA version: 15.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2012-002672-13-GB

Lead Sponsor: niversity of Oxford, Clinical Trials and Research Governance Office

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 2616

Inclusion Criteria

•Participant is willing and able to give informed consent for participation in the study.
•Male or Female, aged 18 years or above.
•Evidence of stage 3b CKD using the MDRD equation. This includes patients on the CKD register undergoing annual monitoring who have had 2 or more recent samples in the 3b range. as well as patients with at least two consecutive blood samples within the preceding 12 months (with a minimum of 6 weeks between tests) and no identifiable reason for a temporary reduction in eGFR. Where only one test has been performed and is in the 3b range, GPs will be reminded that standard care suggests a second confirmatory test.
•Able (in the recruiting GP’s opinion) and willing to comply with all study requirements.
•Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
•Willing to provide contact details to the Research Team, for use at any time should the need arise, on trial related matters.
•If the participant is a female of child-bearing potential, they are willing to ensure effective contraception during the trial period.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 616
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

•Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
•Type 1 diabetes mellitus
•Terminal disease or felt otherwise unsuitable by their GP.
•Chronic heart failure clinical diagnosis or known LVSD with EF<40%.
•Recent myocardial infarction (within 6 months).
•Alcohol or drug abuse.
•Suspected or known current hazardous or harmful drinking, as defined by an alcohol intake of greater than 42 units every week.
•Suspected or known current substance misuse.
•Documented previous hyperkalaemia not thought to be spurious, or intolerance of spironolactone.
•Serum potassium at baseline over 5 mmol/L.
•Documented Addisonian crisis and/or on fludrocortisone.
•Documented symptomatic hypotension or baseline systolic blood pressure under 100mmHg.
•Recent acute kidney injury or admission for renal failure.
•ACR > 70 mg/mmol.
•Prescription of medications with known harmful interactions with spironolactone as documented in the British National Formulary including tacrolimus, lithium and cyclosporine.
•Any other significant disease or disorder which, in the opinion of the recruiting GP, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.