Kidney Failure, ChronicPhase 2PNIC-NaNCT03476460
Sodium Chloride and Contrast Nephropathy
A Phase 2 study testing Oral sodium chloride and Intravenous sodium chloride in people with Kidney Failure, Chronic and Kidney Failure, Acute, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Kidney Failure, Acute, Heart Failure
- What is being tested?
- Oral sodium chloride and Intravenous sodium chloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2014to 29 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients >65 years,
- Both sexes,
- With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min),
- Undergoing CT scan with contrast
- Written informed consent.
Who cannot join
- Estimated glomerular filtration rate <30 ml/min,
- Serum potassium <3.5 mEq/L,
- Infusion of iodine contrast in the previous 15 days,
- Administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion,
- Decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension),
- Allergy to iodine contrast,
- Presence of hyperchloremia or hypernatremia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Oral Sodium Chloride vs iv Sodium Chloride in the Prevention of Contrast Nephropathy in Outpatients
This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.
Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.
Read more
The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol.
Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min, serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.
Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.
Read the detailed description
This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.
Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.
In those patients randomly allocated to oral prophylaxis (n=133), patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. In those patients randomly allocated to receive sodium chloride 0.9% intravenous solution (n=133), patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol (320 mg of iodine/ml, in 100 ml, at an infusion rate of 2-5 ml/sec).
Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min, serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.
Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.
- Being tested
- Oral sodium chloride, Intravenous sodium chloride
- Keywords
- Acute kidney failure, CT scan, Iodine contrast, Sodium chloride
- Medical subject headings
- Kidney Failure, Chronic, Acute Kidney Injury, Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sodium chlorideDrug
Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.
Intravenous sodium chlorideDrug
Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.
| Study group | Role | What they receive |
|---|---|---|
| Oral sodium chloride | Experimental | Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. Receives: Drug: Oral sodium chloride |
| Intravenous sodium chloride | Active comparator | Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. Receives: Drug: Intravenous sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration
Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25%, within 48h after contrast administration
Measured: Within 48h after contrast administration
Secondary outcomes (14)
Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline
Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 24 hours from contrast administration (baseline)
Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline
Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 48 hours from contrast administration (baseline)
Serum Creatinine at 24h From Baseline
Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 24 hours from contrast administration (baseline)
Serum Creatinine at 48h From Baseline
Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 48 hours from contrast administration (baseline)
Cystatin C at 24h From Baseline
Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 24 hours from contrast administration (baseline)
Cystatin C at 48h From Baseline
Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 48 hours from contrast administration (baseline)
Albumin-to-creatinine Ratio at 24h From Baseline
Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 24 hours from contrast administration (baseline)
Albumin-to-creatinine Ratio at 48h From Baseline
Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 48 hours from contrast administration (baseline)
Urea at 24h From Baseline
Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 24 hours from contrast administration (baseline)
Urea at 48h From Baseline
Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 48 hours from contrast administration (baseline)
Serum Sodium at 24h From Baseline
Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 24 hours from contrast administration (baseline)
Serum Sodium at 48h From Baseline
Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 48 hours from contrast administration (baseline)
Serum Potassium at 24h From Baseline
Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 24 hours from contrast administration (baseline)
Serum Potassium at 48h From Baseline
Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Measured: 48 hours from contrast administration (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Apr 2014
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Ministerio de Sanidad, Servicios Sociales e Igualdad
- Responsible party
- Principal investigator, Luis Manzano Espinosa, Hospital Universitario Ramon y Cajal
- Investigators
- Luis Manzano, MD, PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476460
- Sponsor's protocol ID
- EC11-132
- Acronym
- PNIC-Na
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2018
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Availability Statement The data presented in this study are available on request from the corresponding author. The data are not publicly available due to participant confidentiality.
Publications
Suarez Carantona C, Escobar Cervantes C, Fabregate M, Lopez Rodriguez M, Bara Ledesma N, Soto Perez-Olivares J, Ruiz Ortega RA, Lopez Castellanos G, Olavarria Delgado A, Blazquez Sanchez J, Gomez Del Olmo V, Moralejo Martin M, Pumares Alvarez MB, Sanchez Gallego MC, Llacer P, Liano F, Manzano L. Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial. J Clin Med. 2023 Apr 19;12(8):2965. doi: 10.3390/jcm12082965.
PubMed 37109303
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Sodium Chloride vs iv Sodium Chloride in the Prevention of Contrast Nephropathy in Outpatients
- ClinicalTrials.gov ID
- NCT03476460
- Acronym / sponsor ID
- PNIC-Na / EC11-132
- Keywords
- Acute kidney failure, CT scan, Iodine contrast, Sodium chloride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Ministerio de Sanidad, Servicios Sociales e Igualdad
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.
Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.
The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol.
Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min, serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.
Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.
Detailed description
This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.
Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.
In those patients randomly allocated to oral prophylaxis (n=133), patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. In those patients randomly allocated to receive sodium chloride 0.9% intravenous solution (n=133), patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol (320 mg of iodine/ml, in 100 ml, at an infusion rate of 2-5 ml/sec).
Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min, serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.
Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral sodium chloride | Experimental | Drug: Oral sodium chloridePatients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. |
| Intravenous sodium chloride | Active comparator | Drug: Intravenous sodium chloridePatients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients >65 years,
- Both sexes,
- With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min),
- Undergoing CT scan with contrast
- Written informed consent.
Key exclusion criteria (7 listed)
- Estimated glomerular filtration rate <30 ml/min,
- Serum potassium <3.5 mEq/L,
- Infusion of iodine contrast in the previous 15 days,
- Administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion,
- Decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension),
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 |
|---|---|---|
| Oral sodium chloridePatients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. | Drug | Oral sodium chloride |
| Intravenous sodium chloridePatients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. | Drug | Intravenous sodium chloride |
Primary outcome
Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration
Time frame: Within 48h after contrast administration
Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25%, within 48h after contrast administration
14 secondary outcomes
Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline
Time frame: 24 hours from contrast administration (baseline)
Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline
Time frame: 48 hours from contrast administration (baseline)
Serum Creatinine at 24h From Baseline
Time frame: 24 hours from contrast administration (baseline)
Serum Creatinine at 48h From Baseline
Time frame: 48 hours from contrast administration (baseline)
Cystatin C at 24h From Baseline
Time frame: 24 hours from contrast administration (baseline)
Cystatin C at 48h From Baseline
Time frame: 48 hours from contrast administration (baseline)
Albumin-to-creatinine Ratio at 24h From Baseline
Time frame: 24 hours from contrast administration (baseline)
Albumin-to-creatinine Ratio at 48h From Baseline
Time frame: 48 hours from contrast administration (baseline)
Urea at 24h From Baseline
Time frame: 24 hours from contrast administration (baseline)
Urea at 48h From Baseline
Time frame: 48 hours from contrast administration (baseline)
Serum Sodium at 24h From Baseline
Time frame: 24 hours from contrast administration (baseline)
Serum Sodium at 48h From Baseline
Time frame: 48 hours from contrast administration (baseline)
Serum Potassium at 24h From Baseline
Time frame: 24 hours from contrast administration (baseline)
Serum Potassium at 48h From Baseline
Time frame: 48 hours from contrast administration (baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37109303Suarez Carantona C, Escobar Cervantes C, Fabregate M, Lopez Rodriguez M, Bara Ledesma N, Soto Perez-Olivares J, Ruiz Ortega RA, Lopez Castellanos G, Olavarria Delgado A, Blazquez Sanchez J, Gomez Del Olmo V, Moralejo Martin M, Pumares Alvarez MB, Sanchez Gallego MC, Llacer P, Liano F, Manzano L. Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial. J Clin Med. 2023 Apr 19;12(8):2965. doi: 10.3390/jcm12082965.
- Individual participant dataSharing planned: Yes. Data Availability Statement The data presented in this study are available on request from the corresponding author. The data are not publicly available due to participant confidentiality.
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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.
Luis Manzano, MD, PhD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral sodium chloride and Intravenous sodium chloride in people with Kidney Failure, Chronic and Kidney Failure, Acute, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 5 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 20 Mar 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration (time frame: Within 48h after contrast administration). 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 NCT03476460, which also lists 1 linked publication.
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 20 Mar 2025.