End Stage Renal DiseaseNCT06433193
Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
A study testing PAK HD Sorbent Therapy in people with End Stage Renal Disease and ESRD, run by Nextkidney S.A. at 1 site in Singapore.
Trial summary
The purpose of this study is to demonstrate the safety of dialysate regeneration of the PAK HD sorbent cartridge and therapy efficacy of the PAK HD sorbent therapy compared with conventional hemodialysis. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- End Stage Renal Disease, ESRD
- What is being tested?
- PAK HD Sorbent Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Feb 2024to 24 Apr 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 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be adults >/= 21 years old and <80 years old.
- Subjects must be weighing >/= 55kg and <90kg (patient's dry weight).
- Subjects must have stable haemoglobin >/= 10.5g/dL, 2 months prior to enrolment
- Subjects' pre-dialysis serum values must be within the following range, 2 months prior to enrolment:
- Patient allowable serum biochemistry ranges Allowable pre-dialysis serum values Na >/= 132 mmol/L or </= 145mmol/L HCO3 >/= 15mmol/L or </= 30mmol/L K >/= 3.5mmol/L or </= 5.8mmol/L
- Subjects on stable on thrice weekly 4-h HD schedule. Stability is defined as:
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- Haemodynamic stability during dialysis (absence of hypotensive events and symptomatic arrhythmias), no angina pectoris, AND
- No altered level of consciousness during dialysis.
- Subjects with a well-functioning vascular access (native fistula graft):
- capable of providing a blood flow rate of >/= 250 mL/min, AND
- no vascular access revision and stable shunt flow for at least 4 weeks prior to enrolment.
- Subjects capable of understanding the informed consent form and give informed consent.
- Subjects willing and able to comply with study procedures and to attend all study follow-up visits.
- Subjects who are female of reproducible age to practice birth control methods.
- Subjects can be either gender.
Who cannot join
- Subjects with haemoglobin level of <10.5g/dL in any measurement 2 months prior to enrolment.
- Subjects with the following pre-dialysis serum values in any measurement 2 months prior to enrolment:
- sodium concentration <132 mmol/L or > 145mmol/L
- bicarbonate <15mmol/L or >30mmol/L
- plasma potassium concentration <3.5mmol/L or >5.8mmol/L
- urea <15mmol/L or >28 mmol/L
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- Subjects with severe hypertension: systolic blood pressure > /=180 mmHg, diastolic blood pressure >/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment.
- Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention.
- Subjects with impaired liver function. Impaired liver function is defined as an elevated ALT (alanine aminotransferase) by 3-fold orgreater above the upper limit of normal.
- Subjects with episodes of haemolysis in any measurement 3 months prior to enrolment.
- Subjects with a central venous catheter.
- Subjects with vascular access dysfunction (whether or not requiring an intervention), i.e. failure to achieve and/ or sustain a bloodflow of >/=250 mL/min and/or signs of compromised vascular access patency (according to the opinion of the investigator) within 4weeks prior to enrolment.
- Subjects with vascular access related infection less than 4 weeks prior to enrolment
- Subjects requiring an average ultrafiltration volume >2.8 L per 4-h treatment in mid-week dialysis session in the past 4 weeks priorto enrolment.
- Subjects who are on heparin free dialysis
- Subjects who are unable to provide informed consent.
- Subjects who are unable to comply with study procedures.
- Subjects with psychosocial problems which may negatively influence dialysis treatment.
- Subjects who participated in another clinical intervention or device trial less than 12 weeks prior to enrolment, are currentlyparticipating or intend to participate in such a trial.
- Subjects who are pregnant, breast feeding, or planning a pregnancy within the study period.
- Subjects with a life expectancy <1 year.
- Subjects who are anticipating a living donor kidney transplantation within < 2 months of the study period.
- Subjects with recent history of drug and/or alcohol abuse in the last 3 months prior to enrolment.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Hospital Investigational Medicine Unit
Singapore, 119074
About this study
The purpose of this study is to demonstrate the safety of dialysate regeneration of the PAK HD sorbent cartridge and therapy efficacy of the PAK HD sorbent therapy compared with conventional hemodialysis.
Read the detailed description
This clinical trial is being conducted to evaluate the biochemical safety of dialysate regeneration with the PAK HD sorbent cartridge in a limited number of patients and treatments. Therapy efficacy of the PAK HD sorbent therapy will be compared to conventional hemodialysis under the same therapy settings. The trial will use only one single PAK HD sorbent therapy per patient, and a total of 3 patients. The PAK HD therapies will be performed in the middle of the week.
- Conditions
- End Stage Renal Disease, ESRD
- Being tested
- PAK HD Sorbent Therapy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAK HD Sorbent TherapyDevice
Study Period 1:
Subjects will receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, one 4h CHD therapy will be performed at a dialysate flow rate (QD) of 300mL/min, identical to the dialysate flow rate of the PAK HD sorbent therapy. Blood and dialysate samples will be collected during treatment and sent for analysis, for comparison with PAK HD sorbent treatment.
Study Period 2:
Subjects will again receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, a 2h PAK HD +/- 2h CHD therapy will be performed. Blood and dialysate samples will again be collected during treatment and sent for analysis, for comparison with the CHD therapy of the first period. After completion of study period 2 (PAK HD +/- CHD), subjects will be observed for a minimum duration of 1 h in the hospital after which they may go home if the post-dialysis period was uneventful.
| Study group | Role | What they receive |
|---|---|---|
| PAK HD Sorbent Study | Experimental | The study will be performed as a prospective, non-randomised, single arm two-period cross-over study comparing conventional CHD to PAK HD. All adverse events will be recorded and reviewed. Only one subject will enter each study period at a time. Receives: Device: PAK HD Sorbent Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments.
The clinical safety of the PAK HD will be evaluated in terms of the following primary endpoints:
- Absence of serious adverse events (SAE)
- Absence of critical change in patient's clinical condition and vital parameters (Blood pressure, heart rate, body temperature and respiratory rate and pulse oximetry) during treatment.
- Absence of critical change in haematology and biochemistry immediately before the start of therapy and immediately after completion of therapy, including acid-base state, electrolytes, and ammonia.
Measured: 2 weeks
Secondary outcomes (1)
The secondary objective of this study is to evaluate the efficacy of the PAK HD therapy in comparison to CHD, in terms of uremic toxin removal efficacy (urea, creatinine and phosphate).
The therapy efficacy will be evaluated with the secondary endpoint:
- PAK HD therapy provides equivalent toxin clearances for urea, phosphate and creatinine as compared to CHD
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start22 Feb 2024
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nextkidney S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Titus Wai Leong Lau, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433193
- Sponsor's protocol ID
- DIALYSS-CLI-CIP02
- Status last verified
- Mar 2025
- First submitted
- 22 May 2024
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
- ClinicalTrials.gov ID
- NCT06433193
- Acronym / sponsor ID
- DIALYSS-CLI-CIP02
- Conditions
- End Stage Renal Disease, ESRD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Nextkidney S.A.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 29 May 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.
The purpose of this study is to demonstrate the safety of dialysate regeneration of the PAK HD sorbent cartridge and therapy efficacy of the PAK HD sorbent therapy compared with conventional hemodialysis.
Detailed description
This clinical trial is being conducted to evaluate the biochemical safety of dialysate regeneration with the PAK HD sorbent cartridge in a limited number of patients and treatments. Therapy efficacy of the PAK HD sorbent therapy will be compared to conventional hemodialysis under the same therapy settings. The trial will use only one single PAK HD sorbent therapy per patient, and a total of 3 patients. The PAK HD therapies will be performed in the middle of the week.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAK HD Sorbent Study | Experimental | Device: PAK HD Sorbent TherapyThe study will be performed as a prospective, non-randomised, single arm two-period cross-over study comparing conventional CHD to PAK HD. All adverse events will be recorded and reviewed. Only one subject will enter each study period at a time. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must be adults >/= 21 years old and <80 years old.
- Subjects must be weighing >/= 55kg and <90kg (patient's dry weight).
- Subjects must have stable haemoglobin >/= 10.5g/dL, 2 months prior to enrolment
- Subjects' pre-dialysis serum values must be within the following range, 2 months prior to enrolment:
- Patient allowable serum biochemistry ranges Allowable pre-dialysis serum values Na >/= 132 mmol/L or </= 145mmol/L HCO3 >/= 15mmol/L or </= 30mmol/L K >/= 3.5mmol/L or </= 5.8mmol/L
Key exclusion criteria (23 listed)
- Subjects with haemoglobin level of <10.5g/dL in any measurement 2 months prior to enrolment.
- Subjects with the following pre-dialysis serum values in any measurement 2 months prior to enrolment:
- Subjects with severe hypertension: systolic blood pressure > /=180 mmHg, diastolic blood pressure >/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment.
- Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention.
- Subjects with impaired liver function. Impaired liver function is defined as an elevated ALT (alanine aminotransferase) by 3-fold orgreater above the upper limit of normal.
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 |
|---|---|---|
| PAK HD Sorbent TherapyStudy Period 1: Subjects will receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, one 4h CHD therapy will be performed at a dialysate flow rate (QD) of 300mL/min, identical to the dialysate flow rate of the PAK HD sorbent therapy. Blood and dialysate samples will be collected during treatment and sent for analysis, for comparison with PAK HD sorbent treatment. Study Period 2: Subjects will again receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, a 2h PAK HD +/- 2h CHD therapy will be performed. Blood and dialysate samples will again be collected during treatment and sent for analysis, for comparison with the CHD therapy of the first period. After completion of study period 2 (PAK HD +/- CHD), subjects will be observed for a minimum duration of 1 h in the hospital after which they may go home if the post-dialysis period was uneventful. | Device | PAK HD Sorbent Study |
Primary outcome
The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments.
Time frame: 2 weeks
The clinical safety of the PAK HD will be evaluated in terms of the following primary endpoints: 1. Absence of serious adverse events (SAE) 2. Absence of critical change in patient's clinical condition and vital parameters (Blood pressure, heart rate, body temperature and respiratory rate and pulse oximetry) during treatment. 3. Absence of critical change in haematology and biochemistry immediately before the start of therapy and immediately after completion of therapy, including acid-base state, electrolytes, and ammonia.
1 secondary outcome
The secondary objective of this study is to evaluate the efficacy of the PAK HD therapy in comparison to CHD, in terms of uremic toxin removal efficacy (urea, creatinine and phosphate).
Time frame: 2 weeks
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 1 Apr 2025.
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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.
Titus Wai Leong Lau, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAK HD Sorbent Therapy in people with End Stage Renal Disease and ESRD, run by Nextkidney S.A. at 1 site in Singapore.
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 15 inclusion and 23 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 1 Apr 2025. 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 Singapore. 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?
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?
The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments. (time frame: 2 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 Apr 2025.