Effects of Glucocorticoid Therapy on Renal Function in Patients With PA Complicated by CKD After … (NCT07558811) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effects of Glucocorticoid Therapy on Renal Function in Patients With PA Complicated by CKD After Adrenalectomy: A Multicenter RCT
90 participantsStarted 2026-04-22
Plain-language summary
This multicenter randomized controlled trial plans to enroll primary aldosteronism (PA) patients who meet the following criteria: confirmed unilateral dominant secretion by adrenal vein sampling (AVS), willingness to undergo surgery, and coexisting chronic kidney disease (CKD). Participants will be randomly assigned in a 1:1 ratio to one of two groups. To determine whether short-term postoperative hydrocortisone replacement therapy (intervention group) is superior to conventional management (surgery within 7 days after AVS, control group) in terms of reducing the decline in estimated glomerular filtration rate (eGFR) at 12 months after surgery.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed and dated informed consent form.
✓. Age 18-75 years, any gender.
✓. Confirmed diagnosis of primary aldosteronism (PA): positive PA screening test plus positive saline infusion test or captopril challenge test.
✓. Imaging findings indicating unilateral adrenal lesion, with adrenal vein sampling (AVS) confirming unilateral dominant secretion consistent with the lesion side, and planned unilateral adrenalectomy.
✓. Baseline eGFR 30-60 mL/min/1.73 m² OR positive proteinuria.
Exclusion criteria
✕. Use of hydrocortisone within 3 months prior to AVS.
✕. eGFR \< 30 mL/min/1.73 m², or documented acute kidney injury (AKI) within the past 3 months.
✕. Overt cortisol-secreting tumor (clinical Cushing's syndrome) or requirement for long-term hormone replacement therapy.
✕. Severe proteinuria (24-hour urinary protein ≥ 3.5 g or ACR ≥ 300 mg/g).
What they're measuring
1
the change in eGFR from baseline at 12 months post-surgery
Timeframe: the change in eGFR from baseline at 12 months post-surgery