Hemodialysis ComplicationNCT06392516
Ketoacid Analogues Intradialytic Effect on Inflammation
A study testing Ketoacid in people with Hemodialysis Complication, run by RSUP Fatmawati at 1 site in Indonesia.
Trial summary
this study tries to measure the effect of intradialytic ketoacid analogues on inflammatory parameters Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Ketoacid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Apr 2024to 30 Sep 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who undergo hemodialysis two times a week
Who cannot join
- travelling hemodialysis
- acute conditions
- HIV patient
- acute infection
- stroke and immobilized patient
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUP Fatmawati
Jakarta, Jakarta Selatan, 12430
Anggraini Permata Sari, Internist, 6287875825371, anggrainipz@gmail.com
Muhammad Ikhsan Mokoagow, Endocrinologist, 6281584149555, muhammadikhsan@fatmawatihospital.com
About this study
Official title: Effect of Intradialytic Administration of Ketoacid Analogues on Inflammatory Parameters in Patients Undergoing Chronic Hemodialysis Twice a Week
this study tries to measure the effect of intradialytic ketoacid analogues on inflammatory parameters
Read the detailed description
this study will measure inflammation parameters:
- interleukin 6
- malnutrition inflammation score
- neutrophil lymphocyte ratio
- monocyte lymphocyte ratio
- thrombocyte lymphocyte ratio the duration of intervention is 12 weeks
- Conditions
- Hemodialysis Complication
- Being tested
- Ketoacid
- Keywords
- ketoacid analogues, inflammation, hemodialysis
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoacidDrug
250 ml ketoacid two hours before the hemodialysis session ended
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | patient who undergo hemodialysis two times a week |
| intervention | Experimental | will be given parenteral ketoacid analogues intradialytics two times a week Receives: Drug: Ketoacid |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin-6
in pg/mL, no limit values
Measured: 12 weeks
malnutrition inflammation score
consists of ten components, based on subjective complaints combined with albumin serum (in g/dL), serum iron (in micromol/L, and total iron binding capacity (in micromol/L). the sum of all components >5 means have high inflammation status
Measured: 12 weeks
neutrophil lymphocyte ratio
the percentage ratio of neutrophil count and lymphocyte count will be combined to neutrophil lymphocyte ratio
Measured: 12 weeks
monocyte lymphocyte ratio
the percentage ratio of monocyte count and lymphocyte count will be combined to monocyte lymphocyte ratio
Measured: 12 weeks
thrombocyte lymphocyte ratio
the percentage ratio of thrombocyte (in per microliter of blood) and lymphocyte count will be combined to thrombocyte lymphocyte ratio
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start29 Apr 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention and control
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RSUP Fatmawati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anggraini Permata Sari, RSUP Fatmawati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392516
- Sponsor's protocol ID
- RSF_IPDGH_01
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data is restricted only for investigators
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intradialytic Administration of Ketoacid Analogues on Inflammatory Parameters in Patients Undergoing Chronic Hemodialysis Twice a Week
- ClinicalTrials.gov ID
- NCT06392516
- Acronym / sponsor ID
- RSF_IPDGH_01
- Conditions
- Hemodialysis Complication
- Keywords
- ketoacid analogues, inflammation, hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- RSUP FatmawatiUniversity, hospital or other
- Study start
- 29 Apr 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 30 Apr 2024 (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.
this study tries to measure the effect of intradialytic ketoacid analogues on inflammatory parameters
Detailed description
this study will measure inflammation parameters:
- interleukin 6
- malnutrition inflammation score
- neutrophil lymphocyte ratio
- monocyte lymphocyte ratio
- thrombocyte lymphocyte ratio the duration of intervention is 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention and control
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –patient who undergo hemodialysis two times a week |
| intervention | Experimental | Drug: Ketoacidwill be given parenteral ketoacid analogues intradialytics two times a week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient who undergo hemodialysis two times a week
Key exclusion criteria (5 listed)
- travelling hemodialysis
- acute conditions
- HIV patient
- acute infection
- stroke and immobilized patient
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 |
|---|---|---|
| Ketoacid250 ml ketoacid two hours before the hemodialysis session ended | Drug | intervention |
Primary outcome
interleukin-6
Time frame: 12 weeks
in pg/mL, no limit values
malnutrition inflammation score
Time frame: 12 weeks
consists of ten components, based on subjective complaints combined with albumin serum (in g/dL), serum iron (in micromol/L, and total iron binding capacity (in micromol/L). the sum of all components >5 means have high inflammation status
neutrophil lymphocyte ratio
Time frame: 12 weeks
the percentage ratio of neutrophil count and lymphocyte count will be combined to neutrophil lymphocyte ratio
monocyte lymphocyte ratio
Time frame: 12 weeks
the percentage ratio of monocyte count and lymphocyte count will be combined to monocyte lymphocyte ratio
thrombocyte lymphocyte ratio
Time frame: 12 weeks
the percentage ratio of thrombocyte (in per microliter of blood) and lymphocyte count will be combined to thrombocyte lymphocyte ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No. the data is restricted only for investigators
Related trials for Hemodialysis Complication
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketoacid in people with Hemodialysis Complication, run by RSUP Fatmawati at 1 site in Indonesia.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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 Indonesia. 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?
Results are not available in the source record.
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?
interleukin-6 (time frame: 12 weeks). The study lists 5 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 30 Apr 2024.