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Not yet recruitingNCT07558811GRAFT_PAUpdated Apr 30, 2026

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

A Phase 4 interventional study of Intervention_1 in Primary Aldosteronism Due to Adrenal Hyperplasia, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Aldosteronism Due to Adrenal Hyperplasia

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Keywords

  • Primary Aldosteronism
  • chronical kidney disease
  • Glucocorticoid
  • Adrenalectomy
03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 90 is above the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed and dated 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 30-60 mL/min/1.73 m² OR positive proteinuria.

Exclusion criteria

Exclusion Criteria:

  1. Use of hydrocortisone within 3 months prior to AVS.
  2. \< 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. 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 or \< 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • No intervention
    Control_1

    this group will be not given drug

  • Active comparator
    Intervention_1

    this group will be given drug

    Drug: Intervention_1

Interventions

  • DrugIntervention_1

    Postoperative administration of hydrocortisone for one month

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: the change in eGFR from baseline at 12 months post-surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07558811
Lead sponsor
Ruijin Hospital
Responsible party
Xu jianzhong (physician, Ruijin Hospital) — Principal investigator
First posted
Apr 30, 2026
Start date
Apr 22, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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