Chronic Kidney DiseasesPhase 1NCT05780086
Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution
A Phase 1 study testing 30% icodextrin and 10% dextrose in people with Chronic Kidney Diseases, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
This study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- 30% icodextrin and 10% dextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- 3 Feb 2023to 30 Dec 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients covered by the Mexican Social Security Department.
- Adults over the age of eighteen.
- Patients with chronic kidney failure undergoing replacement therapy with peritoneal dialysis.
- Patients with a functional peritoneal dialysis catheter.
- Patients undergoing peritoneal dialysis that was stable in the most recent month (ongoing peritoneal dialysis as an outpatient or ongoing cyclic peritoneal dialysis)
- Patients who wish to participate and who sign the informed consent.
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- If the peritoneal dialysis catheter and the transfer line are compatible with the peritoneal dialysis bag that has a simple luer male connector.
- If treating doctors consider their patient to be clinically euvolemic.
- If patients have undergone a peritoneal equilibrium test and their dialysis prescription has not been changed since the test was carried out
Who cannot join
- Diabetes mellitus type 1 or uncontrolled diabetes (a1c hemoglobin greater than 8%).
- Active infection.
- Serum sodium prior to the study less than 130 mmol/l.
- Serum bicarbonate prior to the study less than 18 mmol/l.
- Patients who have been prescribed standard peritoneal dialysis who only use solutions with the lowest amount of dextrose
- Hemoglobin less than 8 g/dl.
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- Active bleeding.
- Patients prescribed peritoneal dialysis who use a 4.25% dextrose solution at least once a day.
- Patients with a membrane defect or mechanical defect.
- Diastolic dysfunction with an increase in filling pressure according to the echocardiogram.
- Patients with active or suspected peritonitis according to the clinical criterion or their treating doctor.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Mexico City, 06720
Juan B Ivey-Miranda, MD, +52 5543683768, betuel.ivey@gmail.com
About this study
Official title: A Phase I Study to Evaluate the Short-term Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution With 30% Icodextrin and 10% Dextrose in Patients in Peritoneal Dialysis, on a Preliminary Basis
This study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis
Read the detailed description
Phase I clinical trial which will include ten patients currently undergoing chronic peritoneal dialysis treatment. Patients will be hospitalized for the study. The study will consist of replacing conventional peritoneal dialysis solution with a sodium-free 500 ml solution with 30% icodextrin and 10% dextrose with a dwell time of 24 hours.
- Conditions
- Chronic Kidney Diseases
- Being tested
- 30% icodextrin and 10% dextrose
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30% icodextrin and 10% dextroseDrug
Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose
| Study group | Role | What they receive |
|---|---|---|
| 30% icodextrin and 10% dextrose | Experimental | Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose Receives: Drug: 30% icodextrin and 10% dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety defined as the number serious adverse events related to the investigational product
Safety will be described based on the number of serious adverse events that are determined to be related to the investigational product
Measured: During the 24 hour dwell
Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain
Description of pain. Pain will be described in a scale from 0 to 4; 0 is no pain, 1 is mild pain, 2 is moderate pain, 3 is severe pain, and 4 is extreme pain. Pain will be assessed during infusion, then hourly during the 24 hour dwell, and during the draining
Measured: During the 24 hour dwell
Secondary outcomes (2)
Ultrafiltration
Total volume ultrafiltration as determined by the mL obtained during the draining after the 24hr dwell
Measured: During the 24 hour dwell
Sodium excretion with ultrafiltration
Sodium excretion with ultrafiltration will be calculated by multiplying the mL obtained during the draining after the 24hr dwell by the sodium concentration in a sample of peritoneal fluid
Measured: During the 24 hour dwell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start3 Feb 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- Sequana Medical N.V.
- Responsible party
- Principal investigator, Eduardo Almeida Gutiérrez, Instituto Mexicano del Seguro Social
- Investigators
- Juan B Ivey Miranda, MD, Principal investigator, Affiliated to Heart Failure Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780086
- Sponsor's protocol ID
- R-2022-785-034
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Asher JL, Ivey-Miranda JB, Maulion C, Cox ZL, Borges-Vela JA, Mendoza-Zavala GH, Cigarroa-Lopez JA, Silva-Rueda RI, Revilla-Monsalve C, Moreno-Villagomez J, Ramos-Mastache D, Goedje O, Crosbie I, McIntyre C, Finkelstein F, Turner JM, Testani JM, Rao VS. Development of a Novel Intraperitoneal Icodextrin/Dextrose Solution for Enhanced Sodium Removal. Kidney Med. 2024 Nov 16;7(1):100938. doi: 10.1016/j.xkme.2024.100938. eCollection 2025 Jan.
PubMed 39790231
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Short-term Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution With 30% Icodextrin and 10% Dextrose in Patients in Peritoneal Dialysis, on a Preliminary Basis
- ClinicalTrials.gov ID
- NCT05780086
- Acronym / sponsor ID
- R-2022-785-034
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- Sequana Medical N.V.
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Mar 2023 (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 will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis
Detailed description
Phase I clinical trial which will include ten patients currently undergoing chronic peritoneal dialysis treatment. Patients will be hospitalized for the study. The study will consist of replacing conventional peritoneal dialysis solution with a sodium-free 500 ml solution with 30% icodextrin and 10% dextrose with a dwell time of 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30% icodextrin and 10% dextrose | Experimental | Drug: 30% icodextrin and 10% dextroseDwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients covered by the Mexican Social Security Department.
- Adults over the age of eighteen.
- Patients with chronic kidney failure undergoing replacement therapy with peritoneal dialysis.
- Patients with a functional peritoneal dialysis catheter.
- Patients undergoing peritoneal dialysis that was stable in the most recent month (ongoing peritoneal dialysis as an outpatient or ongoing cyclic peritoneal dialysis)
Key exclusion criteria (11 listed)
- Diabetes mellitus type 1 or uncontrolled diabetes (a1c hemoglobin greater than 8%).
- Active infection.
- Serum sodium prior to the study less than 130 mmol/l.
- Serum bicarbonate prior to the study less than 18 mmol/l.
- Patients who have been prescribed standard peritoneal dialysis who only use solutions with the lowest amount of dextrose
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 |
|---|---|---|
| 30% icodextrin and 10% dextroseDwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose | Drug | 30% icodextrin and 10% dextrose |
Primary outcome
Safety defined as the number serious adverse events related to the investigational product
Time frame: During the 24 hour dwell
Safety will be described based on the number of serious adverse events that are determined to be related to the investigational product
Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain
Time frame: During the 24 hour dwell
Description of pain. Pain will be described in a scale from 0 to 4; 0 is no pain, 1 is mild pain, 2 is moderate pain, 3 is severe pain, and 4 is extreme pain. Pain will be assessed during infusion, then hourly during the 24 hour dwell, and during the draining
2 secondary outcomes
Ultrafiltration
Time frame: During the 24 hour dwell
Sodium excretion with ultrafiltration
Time frame: During the 24 hour dwell
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 39790231Asher JL, Ivey-Miranda JB, Maulion C, Cox ZL, Borges-Vela JA, Mendoza-Zavala GH, Cigarroa-Lopez JA, Silva-Rueda RI, Revilla-Monsalve C, Moreno-Villagomez J, Ramos-Mastache D, Goedje O, Crosbie I, McIntyre C, Finkelstein F, Turner JM, Testani JM, Rao VS. Development of a Novel Intraperitoneal Icodextrin/Dextrose Solution for Enhanced Sodium Removal. Kidney Med. 2024 Nov 16;7(1):100938. doi: 10.1016/j.xkme.2024.100938. eCollection 2025 Jan.
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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. This study is not recruiting at the moment.
Juan B Ivey Miranda, MD principal investigator
Affiliated to Heart Failure Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 30% icodextrin and 10% dextrose in people with Chronic Kidney Diseases, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 9 inclusion and 11 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 28 Mar 2023. 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 Mexico. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Juan B Ivey Miranda, MD (+52 5556276900 ext. 22209, betuel.ivey@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety defined as the number serious adverse events related to the investigational product (time frame: During the 24 hour dwell). 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?
On the ClinicalTrials.gov record for NCT05780086, which also lists 1 linked publication.
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 28 Mar 2023.