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Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRD

Study acronym: TCMWINE
StatusUnknown
PhasePhase 2/3
Started
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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Primary completion date: Dec 31, 2023 to Sep 25, 2024v9
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  4. Primary completion date: Dec 2022 to Dec 31, 2023
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    • Eligibility criteria shortened, about 3 words
    v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoints: 2 to 3v5 Show 11 more changesShow less
    • Enrollment target: 56 to 60
    • Primary completion date: Aug 2022 to Dec 2022
    • Study completion date: Dec 31, 2022 to Dec 31, 2023
    • Start date: Jul 1, 2019 to Jul 4, 2019
    • Interventions: Immunosuppressive Agents (Drug), Optimized Supportive Care (Other), The Yi-Qi-Qing-Jie Herbal Compound (Drug), Yi-Qi-Qing-Jie herbal… to Immunosuppressants (Drug), Optimized Supportive Care (Other), The Yi-Qi-Qing-Jie herbal compound (Drug), Yi-Qi-Qing-Jie herbal compound…
    • Eligibility criteria expanded, about 74 words
    • Secondary endpoints revised (3)
    • Study description shortened, about 15 words
    • Site contact updated
    • Collaborators expanded, about 6 words
    • Study title shortened, about 1 word
  2. Primary completion date: Aug 2021 to Aug 2022
    • Start date: Apr 1, 2018 to Jul 1, 2019
    • Study completion date: Aug 31, 2021 to Dec 31, 2022
    v4
  3. Phase: Not applicable to Phase 2/3v3 Show 8 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 2021 to Aug 2021
    • Study completion date: May 2021 to Aug 31, 2021
    • Start date changed from estimate of Mar 15, 2018 to Apr 1, 2018
    • Interventions: Immunosuppressive Therapy (Drug), Optimized Supportive Care (Drug), The Yi-Qi-Qing-Jie Formula Decoction (Drug) to Immunosuppressive Agents (Drug), Optimized Supportive Care (Other), The Yi-Qi-Qing-Jie Herbal Compound (Drug), Yi-Qi-Qing-Jie herbal…
    • Site details revised
    • Study description expanded, about 4 words
    • Study title expanded, about 1 word
  4. Primary completion date: Mar 2019 to Mar 2021
    • Start date: Feb 1, 2018 to Mar 15, 2018
    • Study completion date: May 2019 to May 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. Based on optimal supportive care, the trial is aiming to assess superiority with regard to renal protection and reduction of severe treatment-related adverse events of Yi-Qi-Qing-Jie formula (YQF) combined therapy compared with immunosuppression monotherapy in high-risk IgAN.
Trial Details
NCT Number NCT03418779
Lead Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: China Academy of Chinese Medical Sciences
Conditions
(from sponsor)		 IgA Nephropathy at High Risk of Developing ESRD
Related terms Glomerulonephritis, IGA
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov