NCT07558811Not yet recruitingPhase 4
Effects of Glucocorticoid Therapy on Renal Function in Patients With PA Complicated by CKD After Adrenalectomy: A Multicenter RCT
Effects of Glucocorticoid Therapy on Renal Function in Patients With Primary Aldosteronism Complicated by Chronic Kidney Disease After Adrenalectomy: A Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 23 Apr 2026
- Start date
- 22 Apr 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07558811
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 90
- From 22 Apr 2026 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of hydrocortisone within 3 months prior to AVS.
- Inability to tolerate surgery.
Other illness
- Overt cortisol-secreting tumor (clinical Cushing's syndrome) or requirement for long-term hormone replacement therapy.
- NYHA class III-IV heart failure, or acute coronary syndrome or stroke within the past 3 months.
- Severe allergy to hydrocortisone or history of serious adverse reactions to hydrocortisone.
- Active malignancy or life expectancy \< 1 year.
- Inability to comply with follow-up as judged by the investigator, or any other condition deemed unsuitable for study participation.
Lab values
- eGFR \< 30 mL/min/1.73 m², or documented acute kidney injury (AKI) within the past 3 months.
Other
- Severe proteinuria (24-hour urinary protein ≥ 3.5 g or ACR ≥ 300 mg/g).
- Pregnancy, lactation, or planned pregnancy in the near future.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.