chronic kidney disease MedDRA version: 14.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Spironolactone
Product Name: Spironolactone
Pharmaceutical Form: Capsule
INN or Proposed INN: Spironolactone
Pharmaceutical form of the placebo: Capsule
Route of administration of the plac
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 18 years 2. Diagnosis of CKD Stage 3 (eGFR 30-59 ml/min/1.73m2) using the MDRD (Modification of Diet in Renal Disease) equation. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: •Diabetes Mellitus •Terminal disease or felt otherwise unsuitable by their general practitioner (GP) •Chronic heart failure i.e. a clinical diagnosis or known ejection fraction (EF) 70 mg/mmol (will require specialist referral if not already made) •Serum potassium = 5 mmol/L on screening blood test •Concomitant co-trimoxazole medication •Concomitant angiotensin-converting enzyme inhibitor AND angiotensin II receptor blocker medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patients with reduced kidney function (kidney disease) have high rates of hardening of the blood vessels, which leads to early heart disease and strokes. Previous research has shown that using low dosage of a 'water tablet', spironolactone in patients with early kidney disease in a hospital outpatient setting improved heart structure and function as well as reduced blood vessel stiffness. STOP-CKD study aims to determine if blood vessel stiffness can be safely reduced with the use of low dose spironolactine in people with early stage kidney disease managed at general practices. ;Secondary Objective: The study also aims to examine: 1. Rate of side effects and safety of the use of spironolactone in people with early stage kidney disease. 2. Patients' and health care professionals’ views to kidney disease, the use of spironolactone in people with early stage kidney disease in a primary care setting as well as their views to research study in the primary care. 3. Recruitment rate of participants to the study. In addition to addressing the above questions, this pilot study (small scale preliminary study) is to test the feasibility of a full-scale definitive study to determine whether cardiovascular events might be safely be reduced with the use of spironolactone in addition to standard management of early stage kidney disease in primary care setting. ;Primary end point(s): The primary outcome measure for the study is the change of pulse wave velocity (measurement of arterial stiffness).;Timepoint(s) of evaluation of this end point: 1. Baseline (at commencement of trial medication) 2. At week 40 (40 weeks after commencement of trial medication). Trial medication will be stopped at week 40. 3. At 46 week (6 weeks after stopping the trial medication) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are: •Change in blood pressure •Change in estimated Glomerular Filtration Rate (eGFR) •Change in urinary albumin to creatinine ratio (ACR) •Change of pulse wave characteristics •Incidence of hyperkalaemia •Incidence of hypotension (20mmHg systolic drop on standing) •Incidence of side-effects •Incidence of other adverse events or adverse reaction defined by the Medicines and Healthcare products Regulatory Agency (MHRA) •Health status as measured by EQ5D Subgroup study will also examine: •Difference in serum potassium reading using two different methods of transport and analysis •Qualitative data outcome on patients’ and primary care physicians’ attitudes towards spironolactone in CKD in community setting and the potential barriers exist to its use. •Qualitative data outcome on patients’ attitudes to CKD and research in CKD in a community setting and the potential barriers exist for participation. ;Timepoint(s) of evaluation of this end point: The timepoints of evaluation of all these end points are at baseline, week 40 and week 46. There will also be continuous evaluation of the incidence of hyperkalaemic, hypotension, side effection of trial medication and other adverse events or reactions throughtout the study period. | — |
Countries
United Kingdom
Contacts
Public ContactKhai Ping Ng
University of Birmingham
Outcome results
None listed