Suitability of a High-energy, Low-protein Formula (Renalive® LP)

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Re-verified, no change to tracked fields
  2. Notable Primary and study completion dates: Apr 21, 2026 to Dec 31, 2027 Show 7 more changesShow less
    • Sponsor refiled this as recruiting (was completed)
    • Enrollment target: 74 to 80
    • Interventions: Renalive® LP, flavour Cappuccino (Dietary Supplement), Renalive® LP, flavour Vanilla (Dietary Supplement) to Renalive® LP, (Dietary Supplement)
    • Eligibility criteria shortened, about 263 words
    • Secondary endpoints shortened, about 133 words
    • Site details revised at 2 of 2 sites
    • Study title shortened, about 12 words
  3. Minor Secondary endpoints revised (10)v6
  4. Minor Eligibility criteria revised
    • Secondary endpoints revised (10)
    v5
  5. Minor Re-verified, no change to tracked fieldsv4
  6. Minor Trial completedv3 Show 4 more changesShow less
    • Enrollment target: estimated 80 to confirmed 74
    • Study sites: 3 to 2
    • Primary and study completion dates changed from estimate of Apr 30, 2026 to Apr 21, 2026
    • Eligibility criteria revised
  7. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 1 to 3
    • Primary completion date: Nov 15, 2025 to Apr 30, 2026
    • Start date changed from estimate of May 1, 2025 to Jun 4, 2025
    • Eligibility criteria revised
  8. Minor Study First Submitted
  • 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.
Inclusion criteria (1) Diagnosed with chronic kidney disease stage 3b-5 (with history of eGFR\<45 mL/min/1.73 m2) Exclusion criteria (1) Has received dialysis or are expected to start dialysis within the next 3 months.
Trial Details
NCT Number NCT06892249
Lead Sponsor Fresenius Kabi Taiwan Ltd.
Conditions
(from sponsor)
CKD, Low Protein Dietary Intake, Malnutrition (Calorie)
Related terms Malnutrition
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov