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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suitability of a High-energy, Low-protein Formula (Renalive® LP)
- ClinicalTrials.gov ID
- NCT06892249
- Acronym / sponsor ID
- Rena-001-CEN
- Conditions
- CKD, Low Protein Dietary Intake, Malnutrition (Calorie)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fresenius Kabi Taiwan Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renalive® LP | Experimental | Dietary Supplement: Renalive® LP, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with chronic kidney disease stage 3b-5 (with history of eGFR<45 mL/min/1.73 m2)
Key exclusion criteria (1 listed)
- Has received dialysis or are expected to start dialysis within the next 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renalive® LP,flavour | Dietary supplement | Renalive® LP |
Primary outcome
Change in body weight from Baseline to end of treatment at Week 4 (Week 4 - Baseline)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight from Baseline to end of treatment at Week 4 (Week 4 - Baseline) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.