Acute Kidney InjuryNCT05629273
Long Term Renal Function After CRRT in the Paediatric Intensive Care Unit, a Follow-up Study.
An observational study of Acute Kidney Injury and Multi Organ Failure, run by Region Stockholm at 1 site in Sweden.
Trial summary
In this study the investigators will evaluate the long-term renal function in children treated with continuous renal replacement therapy (CRRT) due to acute kidney injury (AKI) and multiple organ failure (MOF) in the pediatric intensive care unit (PICU). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Kidney Injury, Multi Organ Failure, Children, Only
- How many people
- 156 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2022to 12 Oct 2024
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Children treated with CRRT in the intensive care unit.
Who may be able to join
- Age newborn to 18 when admitted to ICU. CRRT treatment 2008-2021 due to AKI stage ≥ stage 1 (according to KDIGO) and/or ≥ 2 organ failures
Who cannot join
- CRRT due to metabolic and/or endocrinologic comorbidity.
- Chronic renal failure before CRRT.
- Previous renal transplantation.
- Prospective part:
- Not a resident of Stockholm County and no planned follow up at Karolinska University Hospital.
- Retrospective part:
- Patient referred to Karolinska University Hospital from a hospital outside Sweden.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Pediatric Perioperative Medicine and Intensive Care
Stockholm, Sweden, 171 76
About this study
In this study the investigators will evaluate the long-term renal function in children treated with continuous renal replacement therapy (CRRT) due to acute kidney injury (AKI) and multiple organ failure (MOF) in the pediatric intensive care unit (PICU). These children are not always referred for nephrology follow up after their ICU stay and it is unclear to what extent the patients suffer from chronic renal disease. The primary aim is to establish the frequency of chronic kidney disease (CKD) in children treated with CRRT due to AKI. Secondary outcomes will include mortality, frequency of end stage-renal disease (ESRD) and need for hemodialysis and/or renal transplantation.
Read the detailed description
-Background: Children receiving CRRT due to AKI are a group of severely ill patients. The mortality is high, varying from 16-58 % in different studies (1). Degree of fluid overload at CRRT start is an independent risk factor for PICU mortality (2). MOF and low weight also contribute to a significantly increased mortality rate (3).
Previous studies on adults have shown that CRRT in the ICU is an independent risk factor for both in-hospital and long-term mortality, as well as the development of CKD and end-stage renal disease. Patients with continued impaired renal function at ICU discharge are at higher risk, but patients with complete recovery of their AKI are also at risk of adverse long-term outcomes (4). Data describing the incidence of chronic renal disease after pediatric CRRT are scarce.
Many pediatric ICU patients with AKI don´t have clinical signs of renal damage after ICU discharge (5-8). However, the kidneys do have a capacity to compensate for renal damage and subclinical decreased renal function is not always detected. Subclinical renal damage in children can over the years develop into more severe renal damage and significant symptoms may appear later in life. Recent data show that AKI in the pediatric ICU leads to increased long-term mortality as well as renal damage (5, 9, 10). However, these studies mainly include older children and also covers milder degrees of AKI. Studies investigating long term outcomes after pediatric CRRT are needed. Moreover, it is important to identify risk factors for the development of chronic renal disease in these children in order to initiate adequate follow up and preventive treatment.
-Methods: This is a combined retrospective and prospective single center observational cohort study. All pediatric patients treated with CRRT from 2008 to 2021 at Karolinska University Hospital in Stockholm will be evaluated for enrollment. Data regarding patient characteristics in the PICU and CRRT data will retrospectively be collected from their medical chart. These data include age and weight at CRRT initiation and hospital discharge, comorbidities, reason for ICU admission, mechanical ventilation and ECMO treatment. Data regarding renal function include CRRT indication, KDIGO and PELOD 2 stage at CRRT initiation, serum-creatinine, serum-chloride at CRRT initiation, serum-creatinine at PICU discharge, urine dipstick and urine-albumin/creatinine ratio.
For patients with no nephrology follow-up after CRRT treatment, the renal function will be evaluated by a pediatric nephrologist. Due to practical matters however, this is only possible for patients from the Stockholm area and patients with ongoing care at Karolinska University Hospital. Renal function will be evaluated using serum Creatinine and Cystatin C. Follow-up will also include urine dipstick, urine albumin/creatinine ratio and blood pressure. Further investigations, such as renal ultrasonography or scintigraphy will be performed if deemed clinically relevant. For patients that have already had nephrology follow-up after CRRT, data will be collected from patient charts.
A substantial number of patients will be lost to prospective follow-up due to the high mortality in this group of patients and the fact that many patients are referred to Karolinska University Hospital from other regions in Sweden.
In order to describe the mortality and the risk of symptomatic chronic renal disease after pediatric CRRT the investigators will also conduct a retrospective register-based study of all children who received CRRT due to AKI and/or CRRT at Karolinska University Hospital from 2008-2021. Data regarding mortality, cause of death and diagnosis of chronic renal disease will be collected from the Swedish National Patient Register and National Cause of Death Register. Patients referred from outside Sweden will be excluded from this part of the study.
- Conditions
- Acute Kidney Injury, Multi Organ Failure, Children, Only
- Keywords
- Acute kidney injury, Multi organ failure, Children, Long term complications, Chronic renal damage
- Medical subject headings
- Acute Kidney Injury, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children treated with continuous renal replacement therapy in the intensive care unit. | Children treated with CRRT in the ICU due to AKI stage ≥1 (according to KDIGO) and/or ≥2 organ failures. The aim is to evaluate their long term renal function and establish the frequency of chronic kidney disease. Nephrology follow up will be done by a pediatric nephrologist for children living in the Stockholm area or have ongoing care at Karolinska University Hospital. Due to high mortality in this group of patients and the fact that many patients are referred to Karolinska University Hospital from other regions in Sweden, a substantial number of patients will be lost to follow-up. The investigators will therefore conduct a register-based study of all children who received CRRT due to AKI and/or MOF at Karolinska University Hospital from 2008-2021. Data regarding mortality, cause of death and diagnosis of chronic renal disease will be collected from the Swedish National Patient Register and National Cause of Death Register. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic renal disease (CKD)
Frequency of chronic renal disease (CKD) according to KDIGO definitions at nephrology follow-up.
Measured: Up to12 years.
Chronic renal disease (CKD)
Frequency of chronic renal disease according to ICD diagnosis in Swedish National Patient Register.
Measured: Up to 12 years
Secondary outcomes (7)
Hypertension
Frequency of hypertension at nephrology follow-up.
Measured: Up to 12 years
End-stage renal disease
Frequency of end-stage renal disease defined as the need for renal transplantation or dialysis at nephrology follow up.
Measured: Up to 12 years
Hypertension
Frequency of hypertension according to ICD diagnosis in Swedish National Patient Register.
Measured: Up to 12 years
Dialysis Therapy.
Frequency of dialysis therapy according to Swedish National Patient Register.
Measured: Up to 12 years
Renal transplantation
Frequency of renal transplantation according to Swedish National Patient Register
Measured: Up to 12 years
Mortality
PICU mortality
Measured: Up to 1 year
Mortality
All-cause mortality
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start20 Jan 2022
- Primary completion12 Oct 2024
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Urban Fläring, Principal investigator, Children Perioperative Medicine & Intensive Care, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629273
- Sponsor's protocol ID
- 2022-01669-02
- Status last verified
- Apr 2024
- First submitted
- 7 Nov 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Almarza S, Bialobrzeska K, Casellas MM, Santiago MJ, Lopez-Herce J, Toledo B, Carrillo A. [Long-term outcomes of children treated with continuous renal replacement therapy]. An Pediatr (Barc). 2015 Dec;83(6):404-9. doi: 10.1016/j.anpedi.2014.12.018. Epub 2015 Feb 13. Spanish.
PubMed 25683273Andersson A, Norberg A, Broman LM, Martensson J, Flaring U. Fluid balance after continuous renal replacement therapy initiation and outcome in paediatric multiple organ failure. Acta Anaesthesiol Scand. 2019 Sep;63(8):1028-1036. doi: 10.1111/aas.13389. Epub 2019 Jun 3.
PubMed 31157412Sutherland SM, Zappitelli M, Alexander SR, Chua AN, Brophy PD, Bunchman TE, Hackbarth R, Somers MJ, Baum M, Symons JM, Flores FX, Benfield M, Askenazi D, Chand D, Fortenberry JD, Mahan JD, McBryde K, Blowey D, Goldstein SL. Fluid overload and mortality in children receiving continuous renal replacement therapy: the prospective pediatric continuous renal replacement therapy registry. Am J Kidney Dis. 2010 Feb;55(2):316-25. doi: 10.1053/j.ajkd.2009.10.048. Epub 2009 Dec 30.
PubMed 20042260Wu L, Zhang P, Yang Y, Jiang H, He Y, Xu C, Yan H, Guo Q, Luo Q, Chen J. Long-term renal and overall survival of critically ill patients with acute renal injury who received continuous renal replacement therapy. Ren Fail. 2017 Nov;39(1):736-744. doi: 10.1080/0886022X.2017.1398667.
PubMed 29199512Askenazi DJ, Feig DI, Graham NM, Hui-Stickle S, Goldstein SL. 3-5 year longitudinal follow-up of pediatric patients after acute renal failure. Kidney Int. 2006 Jan;69(1):184-9. doi: 10.1038/sj.ki.5000032.
PubMed 16374442Hayes LW, Oster RA, Tofil NM, Tolwani AJ. Outcomes of critically ill children requiring continuous renal replacement therapy. J Crit Care. 2009 Sep;24(3):394-400. doi: 10.1016/j.jcrc.2008.12.017. Epub 2009 Mar 27.
PubMed 19327959Diane Mok TY, Tseng MH, Chiang MC, Lin JL, Chu SM, Hsu JF, Lien R. Renal replacement therapy in the neonatal intensive care unit. Pediatr Neonatol. 2018 Oct;59(5):474-480. doi: 10.1016/j.pedneo.2017.11.015. Epub 2017 Dec 21.
PubMed 29396136Morelli S, Ricci Z, Di Chiara L, Stazi GV, Polito A, Vitale V, Giorni C, Iacoella C, Picardo S. Renal replacement therapy in neonates with congenital heart disease. Contrib Nephrol. 2007;156:428-33. doi: 10.1159/000102134.
PubMed 17464154Calderon-Margalit R, Golan E, Twig G, Leiba A, Tzur D, Afek A, Skorecki K, Vivante A. History of Childhood Kidney Disease and Risk of Adult End-Stage Renal Disease. N Engl J Med. 2018 Feb 1;378(5):428-438. doi: 10.1056/NEJMoa1700993.
PubMed 29385364Mammen C, Al Abbas A, Skippen P, Nadel H, Levine D, Collet JP, Matsell DG. Long-term risk of CKD in children surviving episodes of acute kidney injury in the intensive care unit: a prospective cohort study. Am J Kidney Dis. 2012 Apr;59(4):523-30. doi: 10.1053/j.ajkd.2011.10.048. Epub 2011 Dec 28.
PubMed 22206744
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Renal Function After CRRT in the Paediatric Intensive Care Unit, a Follow-up Study.
- ClinicalTrials.gov ID
- NCT05629273
- Acronym / sponsor ID
- 2022-01669-02
- Conditions
- Acute Kidney Injury, Multi Organ Failure, Children, Only
- Keywords
- Acute kidney injury, Multi organ failure, Children, Long term complications, Chronic renal damage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 12 Oct 2024 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 29 Nov 2022 (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.
In this study the investigators will evaluate the long-term renal function in children treated with continuous renal replacement therapy (CRRT) due to acute kidney injury (AKI) and multiple organ failure (MOF) in the pediatric intensive care unit (PICU). These children are not always referred for nephrology follow up after their ICU stay and it is unclear to what extent the patients suffer from chronic renal disease. The primary aim is to establish the frequency of chronic kidney disease (CKD) in children treated with CRRT due to AKI. Secondary outcomes will include mortality, frequency of end stage-renal disease (ESRD) and need for hemodialysis and/or renal transplantation.
Detailed description
-Background: Children receiving CRRT due to AKI are a group of severely ill patients. The mortality is high, varying from 16-58 % in different studies (1). Degree of fluid overload at CRRT start is an independent risk factor for PICU mortality (2). MOF and low weight also contribute to a significantly increased mortality rate (3).
Previous studies on adults have shown that CRRT in the ICU is an independent risk factor for both in-hospital and long-term mortality, as well as the development of CKD and end-stage renal disease. Patients with continued impaired renal function at ICU discharge are at higher risk, but patients with complete recovery of their AKI are also at risk of adverse long-term outcomes (4). Data describing the incidence of chronic renal disease after pediatric CRRT are scarce.
Many pediatric ICU patients with AKI don´t have clinical signs of renal damage after ICU discharge (5-8). However, the kidneys do have a capacity to compensate for renal damage and subclinical decreased renal function is not always detected. Subclinical renal damage in children can over the years develop into more severe renal damage and significant symptoms may appear later in life. Recent data show that AKI in the pediatric ICU leads to increased long-term mortality as well as renal damage (5, 9, 10). However, these studies mainly include older children and also covers milder degrees of AKI. Studies investigating long term outcomes after pediatric CRRT are needed. Moreover, it is important to identify risk factors for the development of chronic renal disease in these children in order to initiate adequate follow up and preventive treatment.
-Methods: This is a combined retrospective and prospective single center observational cohort study. All pediatric patients treated with CRRT from 2008 to 2021 at Karolinska University Hospital in Stockholm will be evaluated for enrollment. Data regarding patient characteristics in the PICU and CRRT data will retrospectively be collected from their medical chart. These data include age and weight at CRRT initiation and hospital discharge, comorbidities, reason for ICU admission, mechanical ventilation and ECMO treatment. Data regarding renal function include CRRT indication, KDIGO and PELOD 2 stage at CRRT initiation, serum-creatinine, serum-chloride at CRRT initiation, serum-creatinine at PICU discharge, urine dipstick and urine-albumin/creatinine ratio.
For patients with no nephrology follow-up after CRRT treatment, the renal function will be evaluated by a pediatric nephrologist. Due to practical matters however, this is only possible for patients from the Stockholm area and patients with ongoing care at Karolinska University Hospital. Renal function will be evaluated using serum Creatinine and Cystatin C. Follow-up will also include urine dipstick, urine albumin/creatinine ratio and blood pressure. Further investigations, such as renal ultrasonography or scintigraphy will be performed if deemed clinically relevant. For patients that have already had nephrology follow-up after CRRT, data will be collected from patient charts.
A substantial number of patients will be lost to prospective follow-up due to the high mortality in this group of patients and the fact that many patients are referred to Karolinska University Hospital from other regions in Sweden.
In order to describe the mortality and the risk of symptomatic chronic renal disease after pediatric CRRT the investigators will also conduct a retrospective register-based study of all children who received CRRT due to AKI and/or CRRT at Karolinska University Hospital from 2008-2021. Data regarding mortality, cause of death and diagnosis of chronic renal disease will be collected from the Swedish National Patient Register and National Cause of Death Register. Patients referred from outside Sweden will be excluded from this part of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children treated with continuous renal replacement therapy in the intensive care unit. | – | –Children treated with CRRT in the ICU due to AKI stage ≥1 (according to KDIGO) and/or ≥2 organ failures. The aim is to evaluate their long term renal function and establish the frequency of chronic kidney disease. Nephrology follow up will be done by a pediatric nephrologist for children living in the Stockholm area or have ongoing care at Karolinska University Hospital. Due to high mortality in this group of patients and the fact that many patients are referred to Karolinska University Hospital from other regions in Sweden, a substantial number of patients will be lost to follow-up. The investigators will therefore conduct a register-based study of all children who received CRRT due to AKI and/or MOF at Karolinska University Hospital from 2008-2021. Data regarding mortality, cause of death and diagnosis of chronic renal disease will be collected from the Swedish National Patient Register and National Cause of Death Register. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children treated with CRRT in the intensive care unit.
Key inclusion criteria (1 listed)
- Age newborn to 18 when admitted to ICU. CRRT treatment 2008-2021 due to AKI stage ≥ stage 1 (according to KDIGO) and/or ≥ 2 organ failures
Key exclusion criteria (7 listed)
- CRRT due to metabolic and/or endocrinologic comorbidity.
- Chronic renal failure before CRRT.
- Previous renal transplantation.
- Not a resident of Stockholm County and no planned follow up at Karolinska University Hospital.
- Patient referred to Karolinska University Hospital from a hospital outside Sweden.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic renal disease (CKD)
Time frame: Up to12 years.
Frequency of chronic renal disease (CKD) according to KDIGO definitions at nephrology follow-up.
Chronic renal disease (CKD)
Time frame: Up to 12 years
Frequency of chronic renal disease according to ICD diagnosis in Swedish National Patient Register.
7 secondary outcomes
Hypertension
Time frame: Up to 12 years
End-stage renal disease
Time frame: Up to 12 years
Hypertension
Time frame: Up to 12 years
Dialysis Therapy.
Time frame: Up to 12 years
Renal transplantation
Time frame: Up to 12 years
Mortality
Time frame: Up to 1 year
Mortality
Time frame: Up to 12 years
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 31 Jul 2025.
- Results publication: PubMed 25683273Almarza S, Bialobrzeska K, Casellas MM, Santiago MJ, Lopez-Herce J, Toledo B, Carrillo A. [Long-term outcomes of children treated with continuous renal replacement therapy]. An Pediatr (Barc). 2015 Dec;83(6):404-9. doi: 10.1016/j.anpedi.2014.12.018. Epub 2015 Feb 13. Spanish.
- Results publication: PubMed 31157412Andersson A, Norberg A, Broman LM, Martensson J, Flaring U. Fluid balance after continuous renal replacement therapy initiation and outcome in paediatric multiple organ failure. Acta Anaesthesiol Scand. 2019 Sep;63(8):1028-1036. doi: 10.1111/aas.13389. Epub 2019 Jun 3.
- Results publication: PubMed 20042260Sutherland SM, Zappitelli M, Alexander SR, Chua AN, Brophy PD, Bunchman TE, Hackbarth R, Somers MJ, Baum M, Symons JM, Flores FX, Benfield M, Askenazi D, Chand D, Fortenberry JD, Mahan JD, McBryde K, Blowey D, Goldstein SL. Fluid overload and mortality in children receiving continuous renal replacement therapy: the prospective pediatric continuous renal replacement therapy registry. Am J Kidney Dis. 2010 Feb;55(2):316-25. doi: 10.1053/j.ajkd.2009.10.048. Epub 2009 Dec 30.
- Results publication: PubMed 29199512Wu L, Zhang P, Yang Y, Jiang H, He Y, Xu C, Yan H, Guo Q, Luo Q, Chen J. Long-term renal and overall survival of critically ill patients with acute renal injury who received continuous renal replacement therapy. Ren Fail. 2017 Nov;39(1):736-744. doi: 10.1080/0886022X.2017.1398667.
- Results publication: PubMed 16374442Askenazi DJ, Feig DI, Graham NM, Hui-Stickle S, Goldstein SL. 3-5 year longitudinal follow-up of pediatric patients after acute renal failure. Kidney Int. 2006 Jan;69(1):184-9. doi: 10.1038/sj.ki.5000032.
- Results publication: PubMed 19327959Hayes LW, Oster RA, Tofil NM, Tolwani AJ. Outcomes of critically ill children requiring continuous renal replacement therapy. J Crit Care. 2009 Sep;24(3):394-400. doi: 10.1016/j.jcrc.2008.12.017. Epub 2009 Mar 27.
- Results publication: PubMed 29396136Diane Mok TY, Tseng MH, Chiang MC, Lin JL, Chu SM, Hsu JF, Lien R. Renal replacement therapy in the neonatal intensive care unit. Pediatr Neonatol. 2018 Oct;59(5):474-480. doi: 10.1016/j.pedneo.2017.11.015. Epub 2017 Dec 21.
- Results publication: PubMed 17464154Morelli S, Ricci Z, Di Chiara L, Stazi GV, Polito A, Vitale V, Giorni C, Iacoella C, Picardo S. Renal replacement therapy in neonates with congenital heart disease. Contrib Nephrol. 2007;156:428-33. doi: 10.1159/000102134.
- Results publication: PubMed 29385364Calderon-Margalit R, Golan E, Twig G, Leiba A, Tzur D, Afek A, Skorecki K, Vivante A. History of Childhood Kidney Disease and Risk of Adult End-Stage Renal Disease. N Engl J Med. 2018 Feb 1;378(5):428-438. doi: 10.1056/NEJMoa1700993.
- Results publication: PubMed 22206744Mammen C, Al Abbas A, Skippen P, Nadel H, Levine D, Collet JP, Matsell DG. Long-term risk of CKD in children surviving episodes of acute kidney injury in the intensive care unit: a prospective cohort study. Am J Kidney Dis. 2012 Apr;59(4):523-30. doi: 10.1053/j.ajkd.2011.10.048. Epub 2011 Dec 28.
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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.
Urban Fläring principal investigator
Children Perioperative Medicine & Intensive Care, Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Multi Organ Failure, run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 7 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 31 Jul 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 Sweden. 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?
Chronic renal disease (CKD) (time frame: Up to12 years.). 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 NCT05629273, which also lists 10 linked publications.
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 31 Jul 2025.