Phosphate-Containing Replacement Fluid for Patients Undergoing CRRT

NCT07550894 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: A1805-PL-LC-301
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 15

Brief Summary

Brief Summary: Evaluating a New Phosphate-Containing Fluid for Blood Purification (CRRT) Why is this study being done? Patients in the Intensive Care Unit (ICU) often need a treatment called Continuous Renal Replacement Therapy (CRRT). This is a type of blood purification that acts like an artificial kidney to clear toxins and extra fluid from the body. A common problem during this treatment is that vital minerals, like phosphate, are washed out of the blood along with the toxins. Low phosphate can lead to muscle weakness and breathing problems. Currently, doctors must manually add phosphate to the treatment fluids, which can be inconsistent. This study aims to test a new, pre-mixed fluid that already contains phosphate to see if it works better and is safe. What are the main questions the study aims to answer? Does the new fluid help keep phosphate at a healthy level in the blood during the first 72 hours of treatment? How does the new fluid affect kidney function compared to the standard fluid? Is the new fluid safe for patients to use? Who can take part in this study? The study is looking for adults (18 and older) who: Are in the ICU and need CRRT treatment as decided by their doctor. Are expected to need this treatment for at least 72 hours. Are willing to participate (or have a legal guardian who agrees). People who are pregnant, have known allergies to the fluid ingredients, or have very low blood pressure that cannot be corrected may not be able to join. How will the research happen? This is a "double-blind" study involving 220 participants across 15 hospitals. This means neither the patients nor the doctors will know which fluid is being used until the study is over. Participants will be put into one of two groups by a computer: Group 1 (New Fluid): Receives the blood purification fluid that has phosphate already in it. Group 2 (Standard Fluid): Receives the standard fluid that does not have phosphate. What will participants have to do? Receive Treatment: Participants will receive their assigned fluid during their normal CRRT care for up to 7 days. Blood Tests: Doctors will take regular blood samples to check mineral levels and kidney health. Monitoring: The medical team will closely watch participants for any side effects or safety concerns. Follow-up: There will be a safety check-up 7 days after the treatment ends. Possible Benefits and Risks The new fluid may help prevent low phosphate levels, which could help with recovery. However, as with any medical treatment, there is a risk of side effects or electrolyte imbalances. The research team will monitor every participant 24/7 to ensure their safety.

Conditions

Acute Kidney Injury; Sepsis; Critically Ill Patients Requiring Continuous Renal Replacement Therapy

Keywords

CRRT; Phosphate-containing replacement fluid

Outcome Measures

Primary Outcomes (2)

• Change in Serum Creatinine at 72 Hours

  Percentage change in serum creatinine from baseline to 72 hours to evaluate the non-inferiority of the phosphate-containing fluid in solute clearance.

  72 hours

• Incidence of Hypophosphatemia Within 72 Hours

  Percentage of participants with any measured serum phosphorus \< 0.81 mmol/L during the 72-hour treatment window.

  Up to 72 hours

Secondary Outcomes (17)

• Percentage Change From Baseline in Serum Creatinine

  Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 12-24 hours thereafter until the end of treatment (up to 7 days).

• Sequential Organ Failure Assessment (SOFA) Score

  Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).

• Total Amount of Exogenous Phosphorus Supplementation

  Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.

• Incidence of Exogenous Phosphorus Supplementation

  Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.

• Change From Baseline in Serum Phosphorus Levels

  Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).

Study Arms (2)

Experimental Group: Phosphate-containing Replacement Fluid

EXPERIMENTAL

Participants in this arm will receive the phosphate-containing replacement fluid during Continuous Renal Replacement Therapy (CRRT). The solution is a premixed, electrolyte-balanced fluid containing phosphorus (as phosphate ions). Administration: Delivered via the replacement fluid port of the CRRT machine. Dose/Flow Rate: Standardized according to the study protocol (e.g., 25-35 mL/kg/h) to maintain hemodynamic stability and solute clearance. Duration: Expected intervention duration is 72 hours, with a maximum treatment period of up to 7 days, or until clinical termination of CRRT.

Drug: Phosphate-containing Replacement Fluid

Control Group: Standard Phosphate-free Replacement Fluid

SHAM COMPARATOR

Participants in this arm will receive a standard phosphate-free replacement fluid (Basal replacement solution) during Continuous Renal Replacement Therapy (CRRT). This solution contains standard electrolytes (Sodium, Potassium, Calcium, Magnesium, Chloride) and bicarbonate but lacks phosphate. Administration: Delivered via the replacement fluid port using the same CRRT equipment and settings as the experimental group. Dose/Flow Rate: Managed identically to the experimental group to ensure a comparable dialysis dose. Duration: Expected intervention duration is 72 hours, with a maximum treatment period of up to 7 days, or until clinical termination of CRRT.

Drug: Standard Phosphate-free Replacement Fluid

Interventions

Phosphate-containing Replacement Fluid DRUG

Phosphate-containing Replacement Fluid is an investigational Class 2.3 modified chemical drug approved by the NMPA (No. 2021LP00824). It is a premixed, electrolyte-balanced replacement fluid containing phosphorus. The solution is administered via the extracorporeal circuit during Continuous Renal Replacement Therapy (CRRT). The dosage and flow rate are standardized according to the subject's body weight and clinical requirements (typically 25-35 mL/kg/h).

Experimental Group: Phosphate-containing Replacement Fluid

Standard Phosphate-free Replacement Fluid DRUG

A marketed phosphate-free replacement fluid (standard of care). Administration via extracorporeal circuit with doses identical to the experimental group. Treatment is expected for 72 hours, up to a maximum of 7 days, or until CRRT is clinically terminated. This comparator evaluates the efficacy of the phosphate-containing solution in preventing treatment-induced hypophosphatemia.

Control Group: Standard Phosphate-free Replacement Fluid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• Aged 18 years or older, regardless of gender.
• Meet the clinical indications for Continuous Renal Replacement Therapy (CRRT) as defined by the "Standard Operating Procedures for Blood Purification (2021 Edition)" and assessed by a qualified nephrologist or intensive care physician.
• Expected continuous blood purification duration is 72 hours or longer.
• The participant or their legal guardian has a full understanding of the purpose and significance of the trial, voluntarily agrees to participate and comply with the study procedures, and has signed the written Informed Consent Form (ICF).

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• Known allergy to any component of the investigational drug, or individuals with an allergic constitution.
• Inability to establish suitable vascular access for CRRT.
• Persistent hypotension (Systolic Blood Pressure \< 90 mmHg or Mean Arterial Pressure \< 65 mmHg) that is difficult to correct, unless judged by the investigator as potentially correctable with intervention.
• Presence of malignant tumors with systemic metastasis (except for those who previously underwent radical surgery without recurrence).
• Pregnant or breastfeeding women.
• Receipt of any form of renal replacement therapy (RRT) or blood purification treatment within 24 hours prior to screening.
• Receipt of peritoneal dialysis within 24 hours prior to screening.
• Participation in any other clinical trial involving investigational drugs or devices within 1 month prior to screening.
• Any other condition or reason that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chengdu Qingshan Likang Pharmaceutical Co., Ltd: collaborator

Study Sites (15)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

The Third Affiliated Hospital, Sun Yat-Sen Unive

Guangzhou, Guangdong, China

Location

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Location

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Xi 'An Jiaotong University

Xi'an, Shaanxi, China

Location

Renji Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Related Publications (10)

• Crowley KE, DeGrado JR, Charytan DM. Serum glucose and phosphorus concentrations during continuous renal replacement therapy using commercial replacement solutions with or without phosphorus. Hemodial Int. 2020 Jul;24(3):330-334. doi: 10.1111/hdi.12834. Epub 2020 Apr 29.

  PMID: 32351011 RESULT

• Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.

  PMID: 28219057 RESULT

• Broman M, Carlsson O, Friberg H, Wieslander A, Godaly G. Phosphate-containing dialysis solution prevents hypophosphatemia during continuous renal replacement therapy. Acta Anaesthesiol Scand. 2011 Jan;55(1):39-45. doi: 10.1111/j.1399-6576.2010.02338.x. Epub 2010 Oct 29.

  PMID: 21039362 RESULT

• Godaly G, Carlsson O, Broman M. Phoxilium((R)) reduces hypophosphataemia and magnesium supplementation during continuous renal replacement therapy. Clin Kidney J. 2016 Apr;9(2):205-10. doi: 10.1093/ckj/sfv133. Epub 2015 Dec 19.

  PMID: 26985370 RESULT

• Pistolesi V, Zeppilli L, Fiaccadori E, Regolisti G, Tritapepe L, Morabito S. Hypophosphatemia in critically ill patients with acute kidney injury on renal replacement therapies. J Nephrol. 2019 Dec;32(6):895-908. doi: 10.1007/s40620-019-00648-5. Epub 2019 Sep 12.

  PMID: 31515724 RESULT

• Lim C, Tan HK, Kaushik M. Hypophosphatemia in critically ill patients with acute kidney injury treated with hemodialysis is associated with adverse events. Clin Kidney J. 2017 Jun;10(3):341-347. doi: 10.1093/ckj/sfw120. Epub 2017 Jan 5.

  PMID: 28616212 RESULT

• Hendrix RJ, Hastings MC, Samarin M, Hudson JQ. Predictors of Hypophosphatemia and Outcomes during Continuous Renal Replacement Therapy. Blood Purif. 2020;49(6):700-707. doi: 10.1159/000507421. Epub 2020 Apr 22.

  PMID: 32320987 RESULT

• Demirjian S, Teo BW, Guzman JA, Heyka RJ, Paganini EP, Fissell WH, Schold JD, Schreiber MJ. Hypophosphatemia during continuous hemodialysis is associated with prolonged respiratory failure in patients with acute kidney injury. Nephrol Dial Transplant. 2011 Nov;26(11):3508-14. doi: 10.1093/ndt/gfr075. Epub 2011 Mar 7.

  PMID: 21382993 RESULT

• Pasko DA, Mottes TA, Mueller BA. Pre dialysis of blood prime in continuous hemodialysis normalizes pH and electrolytes. Pediatr Nephrol. 2003 Nov;18(11):1177-83. doi: 10.1007/s00467-003-1258-2. Epub 2003 Oct 2.

  PMID: 14523635 RESULT

• Yessayan L, Yee J, Frinak S, Szamosfalvi B. Continuous Renal Replacement Therapy for the Management of Acid-Base and Electrolyte Imbalances in Acute Kidney Injury. Adv Chronic Kidney Dis. 2016 May;23(3):203-10. doi: 10.1053/j.ackd.2016.02.005.

  PMID: 27113697 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jianfeng Wu, MD PhD

CONTACT

+86-20-87755766 ext 8454; wujianf@mail.sysu.edu.cn

Chuanxi Chen, MD PhD

CONTACT

+86-20-87755766 ext 8454; chenchx23@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding Implementation: This is a double-blind study. Experimental phosphate-containing fluid and standard control fluid are provided in identical 4,000 mL bags with masked labeling to ensure indistinguishable appearance (color, clarity, volume). Randomization \& Independence: Randomization and packaging are managed by an independent unblinded statistician not involved in trial conduct. All parties, including the sponsor, investigators, participants, and outcome assessors, remain blinded to treatment allocation until the official database lock and the Blinded Data Review Meeting (DRM). Unblinding Protocol: A single-stage unblinding occurs only after the database is locked. No interim efficacy analysis is planned. Emergency unblinding via IWRS is permitted only if treatment knowledge is critical for participant safety (e.g., SAEs). Unblinded participants will be withdrawn and documented as dropouts. All emergency unblinding events must be reported to the sponsor within 24 hours.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Critical Care Medicine

Model Details: This is a multicenter, randomized, double-blind, parallel-controlled, Phase III study. A total of 220 eligible participants will be randomized in a 1:1 ratio to either the experimental group (phosphate-containing replacement fluid) or the control group (standard phosphate-free fluid). Stratified Randomization: Randomization is managed via a central Interactive Web Response System (IWRS), stratified by: Baseline Serum Phosphorus: (\< 0.81 mmol/L; 0.81-1.45 mmol/L; \> 1.45 mmol/L). Baseline Serum Creatinine: (≥ 353 μmol/L; \< 353 μmol/L). Blinding Integrity: To maintain the double-blind design, the experimental and control fluids are provided in identical 4,000 mL bags with masked labeling. Participants, investigators, and outcome assessors remain blinded throughout the intervention period.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD and supporting information will be available starting 6 months after the primary results are published in a peer-reviewed journal. The data will remain accessible for a period of 3 years following the initial publication to allow for secondary analyses.
• Access Criteria: De-identified individual participant data will be available to qualified academic researchers who provide a methodologically sound research proposal that is approved by the study's steering committee. Data access will be granted for the purpose of achieving the aims in the approved proposal. To obtain access, requestors must sign a Data Access Agreement (DAA) to ensure participant privacy and data security. Requests should be directed to the corresponding author of the primary publication or the Central Contact listed in this registration.

Locations

CN (15)