Chronic Kidney Disease Trial, Recruiting NCT07216885 Sponsor: Mozarc Medical US LLC Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT07216885
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to give their informed consent to participate
  • People aged 18 years or older
  • People who fall into one of these three groups: those who have been on regular, stable haemodialysis (kidney-filtering treatment using a machine) for at least three months; those who have recently been prescribed haemodialysis for the first time; or those currently on peritoneal dialysis (a different type of kidney filtering) who need to switch to haemodialysis
  • People whose dialysis access point (such as a fistula or catheter) can deliver blood flow at a sufficient rate for the treatment
  • People who understand what the study involves and what will be expected of them
  • People who are willing and able to follow the study requirements, including attending all required treatment sessions and check-ups

Who may not be able to join:

  • People whose body weight when fully drained of excess fluid is 60 kg or under, or 110 kg or over
  • People with a recorded history of regularly missing scheduled dialysis sessions or clinic appointments
  • People who are already scheduled to receive a living kidney transplant within the next two months, who plan to switch to peritoneal dialysis within the next two months, or who need a specific type of dialysis called single needle dialysis
  • People with unstable levels of salts or acids in their blood, as judged by the treating doctor
  • People who have had a major surgery or a serious heart event within the three months before the screening visit
  • People who have had repeated episodes of blood pressure that is too low or too high in the 30 days before screening
  • People with an active or ongoing infection, as judged by the treating doctor
  • People with a known diagnosis of Hepatitis B, Hepatitis C, or HIV
  • People with documented blood clotting disorders, an active or increased risk of bleeding, or who cannot tolerate heparin (a common blood-thinning medication used during dialysis)
  • People who are currently taking part in, or have taken part in, another interventional clinical trial within the four weeks before screening
  • People with other health conditions that the treating doctor believes may conflict with the study's aims or procedures
  • People who are pregnant or breastfeeding, or people who are capable of becoming pregnant and who are unwilling to use a medically accepted form of contraception
  • People with an active cancer diagnosis where life expectancy is estimated to be less than six months, as judged by the treating doctor
  • People whose haemoglobin (a measure of red blood cells) was below 9 g/dL in the 30 days before screening
  • People who have had significant episodes of low blood pressure during dialysis sessions in the 30 days before screening
  • People who experienced shock (a serious drop in blood flow) within the 30 days before screening
  • People who have had active seizures within the six months before screening
  • People with a history of a condition where red blood cells are destroyed abnormally (haemolytic anaemia) or low platelet counts (thrombocytopenia)
  • People with recent problems with their dialysis access point, including reversed line connections, catheter replacement, multiple uses of a clot-clearing medication, or a procedure to remove a clot — all within the 30 days before screening
  • People with a documented history of moderate-to-severe heart failure (classified as NYHA Class III or IV) or severely reduced heart pumping function, as judged by the treating doctor
  • People whose fluid overload is caused by fluid build-up in the abdomen due to severe liver disease (liver cirrhosis)
  • People with a serious, life-threatening disease affecting the joints or immune system (rheumatologic disease)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 877-211-1850

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Mozarc Medical US LLC
Registry
ClinicalTrials.gov
Start date
13 January 2026
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Primary Safety Endpoint; Primary Performance Endpoint

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov