CKDNCT06892249
Suitability of a High-energy, Low-protein Formula (Renalive® LP)
A study testing Renalive® LP, in people with CKD and Low Protein Dietary Intake, run by Fresenius Kabi Taiwan Ltd. at 2 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD, Low Protein Dietary Intake, Malnutrition (Calorie)
- What is being tested?
- Renalive® LP,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTaiwan
- Study dates
- 4 Jun 2025to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic kidney disease stage 3b-5 (with history of eGFR<45 mL/min/1.73 m2)
Who cannot join
- Has received dialysis or are expected to start dialysis within the next 3 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Kaosiung Chang Gung Memorial Hospital
Kaohsiung City
Chih-Chao Dr. Yang, chihchau@cgmh.org.tw
- Recruiting
Taipei TzuChi Hospital
New Taipei City
TingYun Dr. Lin, 886-2-66289779 ext. 2350, water.h2o@hotmail.com
About this study
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.
- Conditions
- CKD, Low Protein Dietary Intake, Malnutrition (Calorie)
- Being tested
- Renalive® LP,
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renalive® LP,Dietary supplement
flavour
| Study group | Role | What they receive |
|---|---|---|
| Renalive® LP | Experimental | Not described Receives: Dietary Supplement: Renalive® LP, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from Baseline to end of treatment at Week 4 (Week 4 - Baseline)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start4 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi Taiwan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892249
- Sponsor's protocol ID
- Rena-001-CEN
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No