## Protocol Section
### Identification Module
**NCT ID:** NCT06433193

**Brief Title:** Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients

**Official Title:** Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients

#### Organization Study ID Info
**ID:** DIALYSS-CLI-CIP02
#### Organization
**Class:** INDUSTRY
**Full Name:** Nextkidney S.A.
### Status Module
#### Completion Date
**Date:** 2024-04-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-24

**Type:** ACTUAL

#### Start Date
**Date:** 2024-02-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Nextkidney S.A.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The primary aim of this early feasibility clinical trial is to assess the biochemical safety of dialysate regeneration with the optimised PAK HDsorbent cartridge in a limited number (n=3) of participants and treatments (one therapy per subject). As a secondary aim, we will assessthe therapy efficacy of the PAK HD sorbent therapy in short-daily hemodialysis (SDHD) and compare it to that of conventional CHD underthe same therapy settings.

Following up from the preceding FIH trial, this continuation aims at demonstrating that the optimised PAK HD sorbent system has overcome previous problems of increased dialysate acidity and provides improved control over the patient's acid-base balance.

### Conditions Module

**Conditions:**

- End Stage Renal Disease

- ESRD

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 3

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: PAK HD Sorbent Therapy

**Label:** PAK HD Sorbent Study

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PAK HD Sorbent Study

**Description:** 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.

**Name:** PAK HD Sorbent Therapy

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The clinical safety of the PAK HD will be evaluated in terms of the following primary endpoints:

a) Absence of serious adverse events (SAE) b) 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.

c) 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.

**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

#### Secondary Outcomes

**Description:** The therapy efficacy will be evaluated with the secondary endpoint:

a) PAK HD therapy provides equivalent toxin clearances for urea, phosphate and creatinine as compared to CHD

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Subjects must be adults \>/= 21 years old and \<80 years old.
2. Subjects must be weighing \>/= 55kg and \<90kg (patient's dry weight).
3. Subjects must have stable haemoglobin \>/= 10.5g/dL 2 months prior to enrolment
4. 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
5. Subjects on stable on thrice weekly 4-h HD schedule. Stability is defined as:

   * Haemodynamic stability during dialysis (absence of hypotensive events and symptomatic arrhythmias), no angina pectoris, AND
   * No altered level of consciousness during dialysis.
6. 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.
7. Subjects capable of understanding the informed consent form and give informed consent.
8. Subjects willing and able to comply with study procedures and to attend all study follow-up visits.
9. Subjects who are female of reproducible age to practice birth control methods.
10. Subjects can be either gender.

Exclusion Criteria:

1. Subjects with haemoglobin level of \<10.5g/dL in any measurement 2 months prior to enrolment.
2. 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
3. Subjects with severe hypertension: systolic blood pressure \> /=180 mmHg, diastolic blood pressure \>/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment.
4. Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention.
5. 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.
6. Subjects with episodes of haemolysis in any measurement 3 months prior to enrolment.
7. Subjects with a central venous catheter.
8. 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.
9. Subjects with vascular access related infection less than 4 weeks prior to enrolment
10. 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.
11. Subjects who are on heparin free dialysis
12. Subjects who are unable to provide informed consent.
13. Subjects who are unable to comply with study procedures.
14. Subjects with psychosocial problems which may negatively influence dialysis treatment.
15. 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.
16. Subjects who are pregnant, breast feeding, or planning a pregnancy within the study period.
17. Subjects with a life expectancy \<1 year.
18. Subjects who are anticipating a living donor kidney transplantation within \< 2 months of the study period.
19. Subjects with recent history of drug and/or alcohol abuse in the last 3 months prior to enrolment.

**Maximum Age:** 79 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Singapore

**Country:** Singapore

**Facility:** National University Hospital Investigational Medicine Unit

**Zip:** 119074

#### Overall Officials

**Official 1:**

**Affiliation:** National University Hospital, Singapore

**Name:** Titus Wai Leong Lau, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: End Stage Renal Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007676

- Term: Kidney Failure, Chronic

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M18008

- Name: Dialysis Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
