Effects of Glucocorticoid Therapy on Renal Function in Patients With PA Complicated by CKD After Adrenalectomy: A Multicenter RCT (GRAFT_PA)

April 23, 2026 updated by: Xu jianzhong, Ruijin Hospital

Effects of Glucocorticoid Therapy on Renal Function in Patients With Primary Aldosteronism Complicated by Chronic Kidney Disease After Adrenalectomy: A Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control_1
this group will be not given drug
Active Comparator: Intervention_1
this group will be given drug
Drug: Intervention_1
Postoperative administration of hydrocortisone for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in eGFR from baseline at 12 months post-surgery
Time Frame: 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.
the change in eGFR from baseline at 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 22, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ruijin2026-216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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