Renal FailurePhase 3NCT03806998
Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure
A Phase 3 study testing Ketoacids in people with Renal Failure, run by University of Chile at 1 site in Chile.
Trial summary
The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Ketoacids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteChile
- Study dates
- Sep 2015to 1 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Estimated glomerular filtration rate of less tan 25/ml/min/1.73m2
- Not on renal substitution therapy
- Absence of severe life threatening concomitant diseases
Who cannot join
- Malignant or renovascular hypertension
- Use of systemic steroids or immunosuppressant drugs
- Alcohol or illicit drug abuse
- A body mass index of less tan 18 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion in Patients With Stage III to IV Renal Failure
The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen
Read the detailed description
Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal substitution therapy, without important concomitant diseases and aged between 40 and 70 years, will be invited to participate in the study. They will be randomly assigned to a group that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3 g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and 0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the intervention a blood sample will be obtained to measure creatinine, urea nitrogen and cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine excretion. The compliance with the dietary prescription and the ketoacid or placebo supplement will be assessed every 2 weeks.
- Conditions
- Renal Failure
- Being tested
- Ketoacids, Placebo
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoacidsDietary supplement
Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks
PlaceboDietary supplement
Provision of placebo capsules similar to active supplement
| Study group | Role | What they receive |
|---|---|---|
| Ketoacid supplementation | Experimental | Will receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight Receives: Dietary Supplement: Ketoacids |
| Placebo | Placebo comparator | Will receive placebo tablets in a dose of 1 tablet every 5 kg of body weight Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated glomerular filtration rate
glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C
Measured: 16 weeks
Urinary urea nitrogen excretion
Measurement of urea nitrogen i na spot urine sample
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study startSep 2015
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assgned to receive the ketoacid supplement or placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio de Salud Metropolitano Sur Oriente
- Responsible party
- Principal investigator, Eduardo Lorca, University of Chile
- Investigators
- Daniel Bunout, MD, Principal investigator, INTA University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806998
- Sponsor's protocol ID
- Ketosterilrenal
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion in Patients With Stage III to IV Renal Failure
- ClinicalTrials.gov ID
- NCT03806998
- Acronym / sponsor ID
- Ketosterilrenal
- Conditions
- Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Servicio de Salud Metropolitano Sur Oriente
- Study start
- Sep 2015 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 16 Jan 2019 (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.
The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen
Detailed description
Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal substitution therapy, without important concomitant diseases and aged between 40 and 70 years, will be invited to participate in the study. They will be randomly assigned to a group that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3 g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and 0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the intervention a blood sample will be obtained to measure creatinine, urea nitrogen and cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine excretion. The compliance with the dietary prescription and the ketoacid or placebo supplement will be assessed every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assgned to receive the ketoacid supplement or placebo
| Arm | Type | Receives |
|---|---|---|
| Ketoacid supplementation | Experimental | Dietary Supplement: KetoacidsWill receive a ketoacid supplement containing 630 mg of ketoacids in a dose of 1 tablet every 5 kg of body weight |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboWill receive placebo tablets in a dose of 1 tablet every 5 kg of body weight |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Estimated glomerular filtration rate of less tan 25/ml/min/1.73m2
- Not on renal substitution therapy
- Absence of severe life threatening concomitant diseases
Key exclusion criteria (4 listed)
- Malignant or renovascular hypertension
- Use of systemic steroids or immunosuppressant drugs
- Alcohol or illicit drug abuse
- A body mass index of less tan 18 kg/m2
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 |
|---|---|---|
| KetoacidsProvision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks | Dietary supplement | Ketoacid supplementation |
| PlaceboProvision of placebo capsules similar to active supplement | Dietary supplement | Placebo |
Primary outcome
Estimated glomerular filtration rate
Time frame: 16 weeks
glomerular filtration rate estimated using the CKD-EPI formula for Cystatin-C
Urinary urea nitrogen excretion
Time frame: 16 weeks
Measurement of urea nitrogen i na spot urine sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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. This study is not recruiting at the moment.
Daniel Bunout, MD principal investigator
INTA University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketoacids in people with Renal Failure, run by University of Chile at 1 site in Chile.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated glomerular filtration rate (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 16 Jan 2019.