Children AKI PatientsPhase 4NCT03892447
The Comparative Effectiveness of Alprostadil,Sodium Ferulate and Dopamine in Pediatric Acute Kidney Injury
A Phase 4 study testing Alprostadil, Sodium Ferulate and Dopamine in people with Children AKI Patients, run by Shengjing Hospital at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a pervasive clinical event in children.It has been independently associated with prolonged hospital stays, risk of in-hospital death and future progression to chronic kidney disease. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Children AKI Patients
- What is being tested?
- Alprostadil, Sodium Ferulate and Dopamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Phase 4
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provide informed consent signed and dated by participants and/or their guardians
- male or female, Asian.
- Aged from 1 to 18 years.
- Patients meet the AKI diagnosis criteria of 2012 Kidney Disease: Improving Global Outcome (SKDIGO) Guideline
Who cannot join
- prerenal or postrenal failure
- Patients need renal replacement therapy
- Patients with hemorrhagic disorders
- Patients in shock
- Patients with multiple organ failure
- History of Alprostadil or Sodium Ferulate or dopamine sensitivity
Show all 10Show fewer
- Patients with heart failure
- Patients with peptic ulcer
- Patients with glaucoma
- Patients with interstitial pneumonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 52-week Multicenter, Randomized, Double-blind, Prospective Study to Evaluate Comparative Effectiveness and Safety of Alprostadil Injection,Sodium Ferulate and Dopamine Injection in Pediatric Acute Kidney Injury
Acute kidney injury (AKI) is a pervasive clinical event in children.It has been independently associated with prolonged hospital stays, risk of in-hospital death and future progression to chronic kidney disease. Except for removal of nephrotoxic agents and optimization of supportive care,there are still no other effective therapeutic options recommended by recent guidelines. Renal ischemia is the main mechanism of AKI, the improving microcirculation therapy would be the effective management to improve the outcome of AKI in children.
Dopamine is a vasodilating drug that in small doses improves renal circulation. Alprostadil have been used in chronic arterial occlusion and Sodium Ferulate in ischemic cerebral vascular disease,they have a similar therapeutic effect of anti-platelet aggregation and vasodilation. Recent research shows that alprostadil might be associated with a significant reduction in postcontrast Scr, blood urine nitrogen (BUN) and Cystatin C (CysC) level and decrease the incidence of contrast-induced nephropathy.The investigators speculate that Alprostadil,Sodium Ferulate and dopamine would be effective in treating AKI in children.
This is a prospective, multicenter, randomized, double-blind, 52-week study. The purpose of this study is to evaluate the comparative effectiveness and safety of Alprostadil,Sodium Ferulate and dopamine in improving the outcome of AKI in children.
Read the detailed description
This study aims to explore the effective treatment of pediatric AKI and improve the outcome. It is a 52-week multicenter, randomized, double-blind,prospective study to evaluate comparative effectiveness and safety of alprostadil injection,sodium ferulate and dopamine injection. This study plans to recruit 8 to 10 centers, with 300 participants randomly divided into 3 groups and given respectively Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d,Sodium Ferulate2~6mg/kg.d,iv,14d,Dopamine3~5ug/kg .min,iv,3h/d,14d.Time of outcome measurement is 1w,2w,4w,24w,52w. Primary Outcome Measures is The change of Serum creatinin from baseline, estimated glomerular filtration rate (eGFR) and urine volume in the participants after the use of the study drug.
- Conditions
- Children AKI Patients
- Being tested
- Alprostadil, Sodium Ferulate, Dopamine
- Keywords
- AKI, Child, Alprostadil, Sodium Ferulate, Dopamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprostadilDrug
Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d
Sodium FerulateDrug
Sodium Ferulate 2~6mg/kg.d,iv,14d
DopamineDrug
Dopamine3～5 ug/kg·min,iv,3 h/d,14d
| Study group | Role | What they receive |
|---|---|---|
| Alprostadil | Experimental | Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d Receives: Drug: Alprostadil; Drug: Dopamine |
| Sodium Ferulate | Active comparator | Sodium Ferulate 2~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d Receives: Drug: Sodium Ferulate; Drug: Dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinin
The change of Serum creatinin from baseline after the use of the study drug.
Measured: baseline, 52 weeks
eGFR
The change of eGFR from baseline after the use of the study drug. eGFR (ml/min/1.73m2)=K×L/SCr. L: Height(cm), SCr: serum creatinin (umol/L),K:36.5
Measured: baseline, 52 weeks
Urine volume
The change of urine volume from baseline after the use of the study drug.
Measured: baseline, 52 weeks
Secondary outcomes (8)
Urinary markers：White Blood Cell (WBC)
Obtained through routine urine examination.
Measured: baseline, 52 weeks
Urinary markers：Red Blood Cell (RBC)
Obtained through routine urine examination.
Measured: baseline, 52 weeks
Urinary markers：Urine protein
Obtained through routine urine examination.
Measured: baseline, 52 weeks
Serum urea
Obtained through renal function test.
Measured: baseline, 52 weeks
Serum Cystatin
Obtained through renal function test.
Measured: baseline, 52 weeks
Three dimensional(3D) color ultrasound Imaging
Size of kidneys,Blood flow of renal arteries.
Measured: baseline, 52 weeks
Blood pressure
Measured: baseline, 52 weeks
Duration of hospital stays
Measured: baseline, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Aug 2019 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children AKI PatientsStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yubin Wu, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892447
- Sponsor's protocol ID
- SJES001
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week Multicenter, Randomized, Double-blind, Prospective Study to Evaluate Comparative Effectiveness and Safety of Alprostadil Injection,Sodium Ferulate and Dopamine Injection in Pediatric Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03892447
- Acronym / sponsor ID
- SJES001
- Conditions
- Children AKI Patients
- Keywords
- AKI, Child, Alprostadil, Sodium Ferulate, Dopamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Mar 2019 (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.
Acute kidney injury (AKI) is a pervasive clinical event in children.It has been independently associated with prolonged hospital stays, risk of in-hospital death and future progression to chronic kidney disease. Except for removal of nephrotoxic agents and optimization of supportive care,there are still no other effective therapeutic options recommended by recent guidelines. Renal ischemia is the main mechanism of AKI, the improving microcirculation therapy would be the effective management to improve the outcome of AKI in children.
Dopamine is a vasodilating drug that in small doses improves renal circulation. Alprostadil have been used in chronic arterial occlusion and Sodium Ferulate in ischemic cerebral vascular disease,they have a similar therapeutic effect of anti-platelet aggregation and vasodilation. Recent research shows that alprostadil might be associated with a significant reduction in postcontrast Scr, blood urine nitrogen (BUN) and Cystatin C (CysC) level and decrease the incidence of contrast-induced nephropathy.The investigators speculate that Alprostadil,Sodium Ferulate and dopamine would be effective in treating AKI in children.
This is a prospective, multicenter, randomized, double-blind, 52-week study. The purpose of this study is to evaluate the comparative effectiveness and safety of Alprostadil,Sodium Ferulate and dopamine in improving the outcome of AKI in children.
Detailed description
This study aims to explore the effective treatment of pediatric AKI and improve the outcome. It is a 52-week multicenter, randomized, double-blind,prospective study to evaluate comparative effectiveness and safety of alprostadil injection,sodium ferulate and dopamine injection. This study plans to recruit 8 to 10 centers, with 300 participants randomly divided into 3 groups and given respectively Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d,Sodium Ferulate2~6mg/kg.d,iv,14d,Dopamine3~5ug/kg .min,iv,3h/d,14d.Time of outcome measurement is 1w,2w,4w,24w,52w. Primary Outcome Measures is The change of Serum creatinin from baseline, estimated glomerular filtration rate (eGFR) and urine volume in the participants after the use of the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprostadil | Experimental | Drug: Alprostadil, Drug: DopamineAlprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d |
| Sodium Ferulate | Active comparator | Drug: Sodium Ferulate, Drug: DopamineSodium Ferulate 2~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Provide informed consent signed and dated by participants and/or their guardians
- male or female, Asian.
- Aged from 1 to 18 years.
- Patients meet the AKI diagnosis criteria of 2012 Kidney Disease: Improving Global Outcome (SKDIGO) Guideline
Key exclusion criteria (10 listed)
- prerenal or postrenal failure
- Patients need renal replacement therapy
- Patients with hemorrhagic disorders
- Patients in shock
- Patients with multiple organ failure
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 |
|---|---|---|
| AlprostadilAlprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d | Drug | Alprostadil |
| Sodium FerulateSodium Ferulate 2~6mg/kg.d,iv,14d | Drug | Sodium Ferulate |
| DopamineDopamine3～5 ug/kg·min,iv,3 h/d,14d | Drug | Alprostadil, Sodium Ferulate |
Primary outcome
Serum creatinin
Time frame: baseline, 52 weeks
The change of Serum creatinin from baseline after the use of the study drug.
eGFR
Time frame: baseline, 52 weeks
The change of eGFR from baseline after the use of the study drug. eGFR (ml/min/1.73m2)=K×L/SCr. L: Height(cm), SCr: serum creatinin (umol/L),K:36.5
Urine volume
Time frame: baseline, 52 weeks
The change of urine volume from baseline after the use of the study drug.
8 secondary outcomes
Urinary markers：White Blood Cell (WBC)
Time frame: baseline, 52 weeks
Urinary markers：Red Blood Cell (RBC)
Time frame: baseline, 52 weeks
Urinary markers：Urine protein
Time frame: baseline, 52 weeks
Serum urea
Time frame: baseline, 52 weeks
Serum Cystatin
Time frame: baseline, 52 weeks
Three dimensional(3D) color ultrasound Imaging
Time frame: baseline, 52 weeks
Blood pressure
Time frame: baseline, 52 weeks
Duration of hospital stays
Time frame: baseline, 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- 2012 SKDIGO GuidelineLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alprostadil, Sodium Ferulate and Dopamine in people with Children AKI Patients, run by Shengjing Hospital at 1 site in China.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Mar 2019. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yubin Wu, Professor (18940257958, wuyb001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinin (time frame: baseline, 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2019.