Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study
NCT07151456 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224
Last updated 2025-09-03
Summary
This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.
Conditions
Interventions
- DRUG
-
Conventional 24-week glucocorticoid regimen
Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5 - 6: Prednisolone 0.8mg/kg/day (max 60mg); Weeks 7 - 8: Prednisolone 0.6mg/kg/day (max 50mg); Weeks 9 - 10: Prednisolone 0.5mg/kg/day (max 40mg); Weeks 11 - 12: Prednisolone 0.4mg/kg/day (max 30mg); Weeks 13 - 16: Prednisolone 0.3mg/kg/day (max 25mg); Weeks 17 - 20: Prednisolone 0.2mg/kg/day (max 15 Weeks 21 - 24: Prednisolone 0.1mg/kg/day (max 10mg).
- DRUG
-
short-term course (12 week) glucocorticoid regimen
Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5-8: Prednisolone 1mg/kg/day (max 80mg) on alternate days; 9-12: Prednisolone 0.5mg/kg/day (max 40mg) on alternate days
Sponsors & Collaborators
-
First Affiliated Hospital of Wenzhou Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
Countries
- China
Study Locations
More Related Trials
-
The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism
NCT06381323 ·Status: COMPLETED ·Phase: PHASE4
-
Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism(ADOPA)
NCT04461535 ·Status: COMPLETED ·Phase: NA
-
Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia
NCT00529841 ·Status: COMPLETED ·Phase: NA
-
Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
NCT00975078 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of TQ05105 Tablets in Subjects With Glucocorticoid-Refractory Acute Graft-Versus-Host Disease (aGVHD)
NCT04941404 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency
NCT01450930 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
NCT00434148 ·Status: COMPLETED ·Phase: PHASE3
-
Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion
NCT06955286 ·Status: RECRUITING
-
Dose-Finding Pilot Study of ACTH in Patients With Idiopathic Membranous Nephropathy
NCT00805753 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers
NCT03752190 ·Status: WITHDRAWN ·Phase: PHASE4
-
Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test
NCT00851942 ·Status: COMPLETED ·Phase: PHASE4
-
Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency
NCT00915343 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)
NCT01438801 ·Status: WITHDRAWN ·Phase: PHASE4
-
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
NCT05772871 ·Status: RECRUITING ·Phase: PHASE4
-
SOM230 Ectopic ACTH-producing Tumors
NCT02780882 ·Status: WITHDRAWN ·Phase: PHASE2
-
Taper Or Abrupt Steroid Stop: TOASSTtrial
NCT03153527 ·Status: RECRUITING ·Phase: PHASE4
-
The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism
NCT02360046 ·Status: TERMINATED ·Phase: NA
-
The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics
NCT02217800 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome
NCT03053271 ·Status: TERMINATED ·Phase: PHASE2
-
Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT)
NCT01546922 ·Status: COMPLETED ·Phase: PHASE4
-
Extension Study to Assess the Safety and Efficacy of Pasireotide in Participants With Cushing's Disease
NCT00171951 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism
NCT04833192 ·Status: UNKNOWN
-
Prediction of Tumor Shrinkage in Acromegaly
NCT00616408 ·Status: COMPLETED
-
Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
NCT06679816 ·Status: RECRUITING ·Phase: PHASE4
-
Glucocorticoids in Patients With IgG4-RD
NCT01758393 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3