End-Stage Renal DiseaseNCT02946528
Urgent-start Peritoneal Dialysis in ESRD Patients：A Multi-center Study
A study testing urgent-start peritoneal dialysis catheter and central venous catheter in people with End-Stage Renal Disease, run by RenJi Hospital at 1 site in China.
Trial summary
Within the last decade, urgent-start peritoneal dialysis(PD) has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, retrospective design, and the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- urgent-start peritoneal dialysis catheter and central venous catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2019to 17 Nov 2021
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible to be included in the study only if all of the following criteria are applicable:
- Age d 18-80 years at the time of signing the informed consent;
- Diagnosed as ESRD;
- Requiring urgent initiation of dialysis due to late presentation or rapid progression of renal disease without a pre-established functional dialysis access;
- Capable of giving signed informed consent.
Who cannot join
- Patients will be excluded from the study if any of the following criteria are applicable:
- patients with severe volume overload with pulmonary edema;
- patients with severe hyperkalemia (>6.5 mmol/L);
- patients with uremia encephalopathy;
- patients with severe liver failure;
- patients with uncorrectable shock;
- (5)patients with severe risk of bleeding or hemorrhagic disease; (6)patients with contraindications of PD including extensive peritoneal fibrosis adhesion, severe skin disease, extensive abdominal infection or extensive abdominal burns, uncorrectable mechanical problems such as herniation of the umbilicus, herniation of the abdomen, bifida of the bladder, valgus of the peritoneum, peritoneal cavity and chest leakage; (7)patients with Intracranial hemorrhage or increased intracranial pressure; (8)patients with uncorrectable shock; (9)patients who cannot establish a vascular access; (10)patients with malignancy; (11)patients with mental disorder; (12)patients with pregnancy or lactation; (13)patients unable or unwilling to provide informed consent for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urgent-start Peritoneal Dialysis to Improve Treatment in ESRD Patients：A Multi-center Clinical Tial
Within the last decade, urgent-start peritoneal dialysis(PD) has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, retrospective design, and the impact of the urgent-start dialysis modality on outcome, especially on short-term complications, has not been directly evaluated. Therefore, we started this multi-centered, prospective, interventional study compared the dialysis-related complications and survival rate directly between urgent-start PD and HD groups with a large sample to determine the feasibility and safety of urgent-start PD as an alternate initial modality of dialysis for patients who require urgent initiation of dialysis therapy.
Read the detailed description
The prevalence of chronic kidney disease (CKD) and end-stage renal disease (ESRD) is on the rise worldwide. Moreover, many patients who progress to ESRD, even with regular nephrology follow-up, do not have a distinct plan at the time of initiating dialysis therapy, resulting in an urgent need for dialysis. Urgent-start dialysis refers to urgent initiation of dialysis for ESRD patients with no pre-established functional vascular access or peritoneal dialysis (PD) catheter. Hemodialysis (HD) is preferred in most centers with a high rate of central venous catheter (CVC) use at the time of initiating dialysis among HD patients. There is a significantly increased risk of infectious complications, thrombosis, and other complications associated with CVC use which negatively affects patient prognosis. Within the last decade, urgent-start PD has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, and the impact of the urgent-start dialysis modality on outcome, especially on short-term complications, has not been directly evaluated. Therefore, we conducted this multicenter, prospective, randomized clinical trial to compare the dialysis-related complications and survival rate directly between urgent-start PD and HD groups with a large sample to determine the feasibility and safety of urgent-start PD as an alternate initial modality of dialysis for patients who require urgent initiation of dialysis therapy.
- Conditions
- End-Stage Renal Disease
- Being tested
- urgent-start peritoneal dialysis catheter, central venous catheter
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urgent-start peritoneal dialysis catheterDevice
Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter.
central venous catheterDevice
Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter.
| Study group | Role | What they receive |
|---|---|---|
| urgent-start peritoneal dialysis | Experimental | All patients in urgent-start peritoneal dialysis arm initiate peritoneal dialysis as urgent-start dialysis modality. Receives: Device: urgent-start peritoneal dialysis catheter |
| urgent-start hemodialysis | Active comparator | All patients in urgent-start hemodialysis arm initiate hemodialysis as urgent-start dialysis modality. Receives: Device: central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of dialysis-related complications
the incidence of dialysis-related complications.Dialysis-related complications were defined as a composite of non-infectious complications (malposition, obstruction, leakage, hernia, bleeding, or thrombosis) and infectious complications (catheterrelated infection, exit-site infection, or peritonitis)
Measured: 12 months
Secondary outcomes (5)
PD catheter technical survival rate
PD catheter technical survival rate
Measured: 12 months
peritonitis-free survival rates
peritonitis-free survival rates
Measured: 12 months
patient survival rate
patient survival rate
Measured: 12 months
total medical cost of initial hospitalization
total medical cost of initial hospitalization
Measured: 6 weeks
duration of initial hospitalization
duration of initial hospitalization
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start26 Feb 2019
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Xin Hua Hospital of Zhejiang Province, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Changhai Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Tong Ren Hospital, Shanghai Jiading District Central Hospital, Shanghai Songjiang District Central Hospital, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Shanghai Punan Hospital
- Responsible party
- Sponsor
- Investigators
- Zhaohui Ni, Doctor, Study chair, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.Gengru Jiang, Doctor, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineNiansong Wang, Doctor, Principal investigator, The Sixth People's Hospital Affiliated to Shanghai Jiao Tong UniversityZhiyong Guo, Doctor, Principal investigator, Changhai HospitalXiaonong Chen, Doctor, Principal investigator, Ruijin HospitalFeng Ding, Doctor, Principal investigator, No.9 People Hospital Affiliated to Shanghai Jiao Tong University School of MedicineWeijie Yuan, Doctor, Principal investigator, Shanghai General Hospital affiliated to Shanghai Jiao Tong UniversityYueyi Deng, Doctor, Principal investigator, Long Hua Hospital Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946528
- Sponsor's protocol ID
- RJ20161021USPD
- Status last verified
- Dec 2023
- First submitted
- 24 Oct 2016
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghaffari A. Urgent-start peritoneal dialysis: a quality improvement report. Am J Kidney Dis. 2012 Mar;59(3):400-8. doi: 10.1053/j.ajkd.2011.08.034. Epub 2011 Oct 22.
PubMed 22019332Alkatheeri AM, Blake PG, Gray D, Jain AK. Success of Urgent-Start Peritoneal Dialysis in a Large Canadian Renal Program. Perit Dial Int. 2016 Mar-Apr;36(2):171-6. doi: 10.3747/pdi.2014.00148. Epub 2015 Sep 15.
PubMed 26374834Wong LP, Li NC, Kansal S, Lacson E Jr, Maddux F, Kessler J, Curd S, Lester K, Herman M, Pulliam J. Urgent Peritoneal Dialysis Starts for ESRD: Initial Multicenter Experiences in the United States. Am J Kidney Dis. 2016 Sep;68(3):500-2. doi: 10.1053/j.ajkd.2016.03.426. Epub 2016 May 11. No abstract available.
PubMed 27178678Povlsen JV, Ivarsen P. How to start the late referred ESRD patient urgently on chronic APD. Nephrol Dial Transplant. 2006 Jul;21 Suppl 2:ii56-9. doi: 10.1093/ndt/gfl192.
PubMed 16825263Ivarsen P, Povlsen JV. Can peritoneal dialysis be applied for unplanned initiation of chronic dialysis? Nephrol Dial Transplant. 2014 Dec;29(12):2201-6. doi: 10.1093/ndt/gft487. Epub 2013 Dec 17.
PubMed 24353321Koch M, Kohnle M, Trapp R, Haastert B, Rump LC, Aker S. Comparable outcome of acute unplanned peritoneal dialysis and haemodialysis. Nephrol Dial Transplant. 2012 Jan;27(1):375-80. doi: 10.1093/ndt/gfr262. Epub 2011 May 28.
PubMed 21622993Lobbedez T, Lecouf A, Ficheux M, Henri P, Hurault de Ligny B, Ryckelynck JP. Is rapid initiation of peritoneal dialysis feasible in unplanned dialysis patients? A single-centre experience. Nephrol Dial Transplant. 2008 Oct;23(10):3290-4. doi: 10.1093/ndt/gfn213. Epub 2008 Apr 19.
PubMed 18424817Povlsen JV, Sorensen AB, Ivarsen P. Unplanned Start on Peritoneal Dialysis Right after PD Catheter Implantation for Older People with End-Stage Renal Disease. Perit Dial Int. 2015 Nov;35(6):622-4. doi: 10.3747/pdi.2014.00347.
PubMed 26702001Liu Y, Zhang L, Lin A, Ni Z, Qian J, Fang W. Impact of break-in period on the short-term outcomes of patients started on peritoneal dialysis. Perit Dial Int. 2014 Jan-Feb;34(1):49-56. doi: 10.3747/pdi.2012.00293.
PubMed 24525597Arramreddy R, Zheng S, Saxena AB, Liebman SE, Wong L. Urgent-start peritoneal dialysis: a chance for a new beginning. Am J Kidney Dis. 2014 Mar;63(3):390-5. doi: 10.1053/j.ajkd.2013.09.018. Epub 2013 Nov 15.
PubMed 24246221Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus haemodialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jan 27;1(1):CD012899. doi: 10.1002/14651858.CD012899.pub2.
PubMed 33501650Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus conventional-start peritoneal dialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 15;12(12):CD012913. doi: 10.1002/14651858.CD012913.pub2.
PubMed 33320346
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urgent-start Peritoneal Dialysis to Improve Treatment in ESRD Patients：A Multi-center Clinical Tial
- ClinicalTrials.gov ID
- NCT02946528
- Acronym / sponsor ID
- RJ20161021USPD
- Conditions
- End-Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Xin Hua Hospital of Zhejiang Province, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Changhai Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Tong Ren Hospital, Shanghai Jiading District Central Hospital, Shanghai Songjiang District Central Hospital, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Shanghai Punan Hospital
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 27 Oct 2016 (estimated)
- 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.
Within the last decade, urgent-start peritoneal dialysis(PD) has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, retrospective design, and the impact of the urgent-start dialysis modality on outcome, especially on short-term complications, has not been directly evaluated. Therefore, we started this multi-centered, prospective, interventional study compared the dialysis-related complications and survival rate directly between urgent-start PD and HD groups with a large sample to determine the feasibility and safety of urgent-start PD as an alternate initial modality of dialysis for patients who require urgent initiation of dialysis therapy.
Detailed description
The prevalence of chronic kidney disease (CKD) and end-stage renal disease (ESRD) is on the rise worldwide. Moreover, many patients who progress to ESRD, even with regular nephrology follow-up, do not have a distinct plan at the time of initiating dialysis therapy, resulting in an urgent need for dialysis. Urgent-start dialysis refers to urgent initiation of dialysis for ESRD patients with no pre-established functional vascular access or peritoneal dialysis (PD) catheter. Hemodialysis (HD) is preferred in most centers with a high rate of central venous catheter (CVC) use at the time of initiating dialysis among HD patients. There is a significantly increased risk of infectious complications, thrombosis, and other complications associated with CVC use which negatively affects patient prognosis. Within the last decade, urgent-start PD has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, and the impact of the urgent-start dialysis modality on outcome, especially on short-term complications, has not been directly evaluated. Therefore, we conducted this multicenter, prospective, randomized clinical trial to compare the dialysis-related complications and survival rate directly between urgent-start PD and HD groups with a large sample to determine the feasibility and safety of urgent-start PD as an alternate initial modality of dialysis for patients who require urgent initiation of dialysis therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urgent-start peritoneal dialysis | Experimental | Device: urgent-start peritoneal dialysis catheterAll patients in urgent-start peritoneal dialysis arm initiate peritoneal dialysis as urgent-start dialysis modality. |
| urgent-start hemodialysis | Active comparator | Device: central venous catheterAll patients in urgent-start hemodialysis arm initiate hemodialysis as urgent-start dialysis modality. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients will be eligible to be included in the study only if all of the following criteria are applicable:
- Age d 18-80 years at the time of signing the informed consent;
- Diagnosed as ESRD;
- Requiring urgent initiation of dialysis due to late presentation or rapid progression of renal disease without a pre-established functional dialysis access;
- Capable of giving signed informed consent.
Key exclusion criteria (7 listed)
- patients with severe volume overload with pulmonary edema;
- patients with severe hyperkalemia (>6.5 mmol/L);
- patients with uremia encephalopathy;
- patients with severe liver failure;
- patients with uncorrectable shock;
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 |
|---|---|---|
| urgent-start peritoneal dialysis catheterPatients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter. | Device | urgent-start peritoneal dialysis |
| central venous catheterPatients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter. | Device | urgent-start hemodialysis |
Primary outcome
the incidence of dialysis-related complications
Time frame: 12 months
the incidence of dialysis-related complications.Dialysis-related complications were defined as a composite of non-infectious complications (malposition, obstruction, leakage, hernia, bleeding, or thrombosis) and infectious complications (catheterrelated infection, exit-site infection, or peritonitis)
5 secondary outcomes
PD catheter technical survival rate
Time frame: 12 months
peritonitis-free survival rates
Time frame: 12 months
patient survival rate
Time frame: 12 months
total medical cost of initial hospitalization
Time frame: 6 weeks
duration of initial hospitalization
Time frame: 6 weeks
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 8 Dec 2023.
- Background: PubMed 22019332Ghaffari A. Urgent-start peritoneal dialysis: a quality improvement report. Am J Kidney Dis. 2012 Mar;59(3):400-8. doi: 10.1053/j.ajkd.2011.08.034. Epub 2011 Oct 22.
- Background: PubMed 26374834Alkatheeri AM, Blake PG, Gray D, Jain AK. Success of Urgent-Start Peritoneal Dialysis in a Large Canadian Renal Program. Perit Dial Int. 2016 Mar-Apr;36(2):171-6. doi: 10.3747/pdi.2014.00148. Epub 2015 Sep 15.
- Background: PubMed 27178678Wong LP, Li NC, Kansal S, Lacson E Jr, Maddux F, Kessler J, Curd S, Lester K, Herman M, Pulliam J. Urgent Peritoneal Dialysis Starts for ESRD: Initial Multicenter Experiences in the United States. Am J Kidney Dis. 2016 Sep;68(3):500-2. doi: 10.1053/j.ajkd.2016.03.426. Epub 2016 May 11. No abstract available.
- Background: PubMed 16825263Povlsen JV, Ivarsen P. How to start the late referred ESRD patient urgently on chronic APD. Nephrol Dial Transplant. 2006 Jul;21 Suppl 2:ii56-9. doi: 10.1093/ndt/gfl192.
- Background: PubMed 24353321Ivarsen P, Povlsen JV. Can peritoneal dialysis be applied for unplanned initiation of chronic dialysis? Nephrol Dial Transplant. 2014 Dec;29(12):2201-6. doi: 10.1093/ndt/gft487. Epub 2013 Dec 17.
- Background: PubMed 21622993Koch M, Kohnle M, Trapp R, Haastert B, Rump LC, Aker S. Comparable outcome of acute unplanned peritoneal dialysis and haemodialysis. Nephrol Dial Transplant. 2012 Jan;27(1):375-80. doi: 10.1093/ndt/gfr262. Epub 2011 May 28.
- Background: PubMed 18424817Lobbedez T, Lecouf A, Ficheux M, Henri P, Hurault de Ligny B, Ryckelynck JP. Is rapid initiation of peritoneal dialysis feasible in unplanned dialysis patients? A single-centre experience. Nephrol Dial Transplant. 2008 Oct;23(10):3290-4. doi: 10.1093/ndt/gfn213. Epub 2008 Apr 19.
- Background: PubMed 26702001Povlsen JV, Sorensen AB, Ivarsen P. Unplanned Start on Peritoneal Dialysis Right after PD Catheter Implantation for Older People with End-Stage Renal Disease. Perit Dial Int. 2015 Nov;35(6):622-4. doi: 10.3747/pdi.2014.00347.
- Background: PubMed 24525597Liu Y, Zhang L, Lin A, Ni Z, Qian J, Fang W. Impact of break-in period on the short-term outcomes of patients started on peritoneal dialysis. Perit Dial Int. 2014 Jan-Feb;34(1):49-56. doi: 10.3747/pdi.2012.00293.
- Background: PubMed 24246221Arramreddy R, Zheng S, Saxena AB, Liebman SE, Wong L. Urgent-start peritoneal dialysis: a chance for a new beginning. Am J Kidney Dis. 2014 Mar;63(3):390-5. doi: 10.1053/j.ajkd.2013.09.018. Epub 2013 Nov 15.
- Derived from this study: PubMed 33501650Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus haemodialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jan 27;1(1):CD012899. doi: 10.1002/14651858.CD012899.pub2.
- Derived from this study: PubMed 33320346Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus conventional-start peritoneal dialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 15;12(12):CD012913. doi: 10.1002/14651858.CD012913.pub2.
- Individual participant dataSharing planned: No
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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.
Zhaohui Ni, Doctor study chair
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Gengru Jiang, Doctor principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Niansong Wang, Doctor principal investigator
The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urgent-start peritoneal dialysis catheter and central venous catheter in people with End-Stage Renal Disease, run by RenJi 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 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 8 Dec 2023. 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.
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?
the incidence of dialysis-related complications (time frame: 12 months). 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 NCT02946528, which also lists 12 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 8 Dec 2023.