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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07558811

Acronym

GRAFT_PA

Enrollment

Registered

2026-04-30

Start date

2026-04-22

Completion date

2028-12-31

Last updated

2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism Due to Adrenal Hyperplasia

Keywords

Primary Aldosteronism, chronical kidney disease, Glucocorticoid, Adrenalectomy

Brief 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.

Interventions

DRUGIntervention_1

Postoperative administration of hydrocortisone for one month

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Signed and dated informed consent form. 2. Age 18-75 years, any gender. 3. Confirmed diagnosis of primary aldosteronism (PA): positive PA screening test plus positive saline infusion test or captopril challenge test. 4. Imaging findings indicating unilateral adrenal lesion, with adrenal vein sampling (AVS) confirming unilateral dominant secretion consistent with the lesion side, and planned unilateral adrenalectomy. 5. Baseline eGFR 30-60 mL/min/1.73 m² OR positive proteinuria.

Exclusion criteria

1. Use of hydrocortisone within 3 months prior to AVS. 2. eGFR \< 30 mL/min/1.73 m², or documented acute kidney injury (AKI) within the past 3 months. 3. Overt cortisol-secreting tumor (clinical Cushing's syndrome) or requirement for long-term hormone replacement therapy. 4. Severe proteinuria (24-hour urinary protein ≥ 3.5 g or ACR ≥ 300 mg/g). 5. NYHA class III-IV heart failure, or acute coronary syndrome or stroke within the past 3 months. 6. Severe allergy to hydrocortisone or history of serious adverse reactions to hydrocortisone. 7. Pregnancy, lactation, or planned pregnancy in the near future. 8. Active malignancy or life expectancy \< 1 year. 9. Inability to tolerate surgery. 10. Inability to comply with follow-up as judged by the investigator, or any other condition deemed unsuitable for study participation.

Design outcomes

Primary

Measure	Time frame	Description
the change in eGFR from baseline at 12 months post-surgery	the change in eGFR from baseline at 12 months post-surgery	To compare the change in eGFR from baseline at 12 months post-surgery between the conventional group and the intervention group.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026