Patiromer Trial in CKD Stage IIIB to V (NCT05786469) | Clinical Trial Compass
TerminatedPhase 3
Patiromer Trial in CKD Stage IIIB to V
Stopped: Unable to reach planned study sample size due to increased patient failure to meet inclusion criteria.
Italy2 participantsStarted 2023-08-02
Plain-language summary
This phase III, prospective, randomized, double-blind, placebo-controlled trial will primarily aim to compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits, one-week apart) in non-dialysis patients with CKD stage IIIB to V receiving best available conservative therapy, including RAAS inhibition with ACE inhibitors and/or ARBs and/or aldosterone antagonists. Patients are expected to be included during an 18-month recruitment period. All randomized patients will be maintained on active follow-up for 12 months. At 12 months, a final visit will be performed for all patients who complete the follow-up period. During this final visit, all the parameters evaluated at baseline will be reassessed and the study treatment will be discontinued. Whenever feasible, a final visit will be planned within one month also for those patients who prematurely discontinue the treatment period for any intercurrent reason (adverse event, consent withdrawal and other). After the final visit the patient will be discharged from the study and will be referred to his nephrologist with the suggestion to check serum potassium levels within three days.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of informed consent prior to any study-specific procedures.
✓. Age \>18 years.
✓. GFR \<45 ml/min/1.73m2 as per CKD-EPI equation.
✓. Serum potassium ≥5.0 mEq/L (in at least two consecutive evaluations, one week apart) despite dietary counseling, optimized metabolic acidosis control, diuretic therapy as needed for blood pressure control and fluid balance, and effective blood glucose control in diabetics.
✓. Concomitant therapy with RAAS inhibitors (ACE inhibitors, ARBs and aldosterone antagonists, such as spironolactone and finerenone).
Exclusion criteria
✕. Ongoing treatment with SPS before randomization (Patient eligibility could be reassessed during the screening period after at least one week from SPS therapy withdrawal)
✕. Rapidly progressive kidney disease (eGFR reduction ≥ 30% over the last three months as per CKD-Epi equation) and expected risk of progression to ESKD and need of renal replacement therapy by dialysis or transplantation within six months.
✕
What they're measuring
1
To compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia
Timeframe: 6 months
Trial details
NCT IDNCT05786469
SponsorMario Negri Institute for Pharmacological Research
✕. Concomitant treatment with steroids or any other immunosuppressive agent.
✕. Hypersensitivity to the active ingredient or any of the excipients. Patients with Hereditary Fructose Intolerance.
✕. Patients with or at risk of hypercalcaemia and/or hypomagnesaemia.
✕. Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months.
✕. Refractory severe hypertension (BP \>180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications and a diuretic).