Acute Renal FailureNCT03976440
Simplified Regional Citrate Anticoagulation Protocols for CVVH, CVVHDF and SLED: a Pilot Study
An observational study of Acute Renal Failure and Dialysis Related Complication, run by University of Parma at 1 site in Italy.
Trial summary
The aim of the study are: 1) To evaluate the occurrence of acid-base alterations and the incidence of hypophosphatemia during different modalities of Renal Replacement Terapy (RRT) in critically ill patients [CVVH, CVVHDF and SLED (Sustained Low-Efficiency Dialysis)] by using a simplified Regional Citrate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, Dialysis Related Complication, Hypophosphatemia
- What is being tested?
- Renal Replacement Therapy (RRT) start
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 31 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients aged >=18 years with severe acute kidney injury (AKI) or end stage renal disease (ESRD) requiring renal replacement therapy
Who may be able to join
- age >= 18 years
- critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for severe acute kidney injury (AKI)
- critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for end stage renal disease (ESRD)
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simplified Regional Citrate Anticoagulation Protocols for CVVH, CVVHDF and SLED Focused on the Prevention of RRT-related Hypophosphatemia and Optimization of Acid-base Balance: a Pilot Study
The aim of the study are: 1) To evaluate the occurrence of acid-base alterations and the incidence of hypophosphatemia during different modalities of Renal Replacement Terapy (RRT) in critically ill patients [CVVH, CVVHDF and SLED (Sustained Low-Efficiency Dialysis)] by using a simplified Regional Citrate Anticoagulation (RCA) protocol combined with the adoption of a phosphate-containing solution as dialysate and/or replacement fluid; 2) To optimize the infusion rates of different solutions adopted, including citrate, in order to obtain an appropriate electrolyte and buffer supply. The final aim of this approach will be to reduce the need for frequent monitoring of acid-base status and electrolytes (with special regard to ionized calcium levels), and to avoid the need for frequent adjustments of RCA-RRT parameters (infusion rate of different solutions, electrolytes supplementation in the course of RRT). This approach could allow to simplify anticoagulation protocols with citrate, in order to minimize potential concerns hampering a wider diffusion of RCA in daily practice.
Read the detailed description
The need for continuous anticoagulation represents a potential drawback of RRT modalities. KDIGO 2012 guidelines on acute kidney injury (AKI) suggest the adoption of RCA as first choice anticoagulation modality for continuous RRT (CRRT) in patients without contraindications for citrate. Citrate has been also introduced as anticoagulant for SLED and its use in the context of a mainly diffusive prolonged intermittent modality has been shown to represent an easy and safe method to maintain the extracorporeal circuit when concentrated citrate solutions, such as ACD-A are used. Hypophosphatemia is a known issue of RRT, and has been reported in up to 50-80% of cases when standard RRT solutions are used, especially in continuous/prolonged intermitted modalities when high RRT doses are delivered. RRT-related phosphate depletion should be avoided in critically ill patients due to the relevant hypophosphatemia-associated complications in this clinical setting. The adoption of phosphate-containing CRRT solutions could reduce the incidence of hypophosphatemia and minimize the need for parenteral phosphorus supplementation.The adoption of a commercially available phosphate-containing CRRT solution, in the setting of RCA-RRT may allow to meet the double target of minimizing RRT-induced hypophosphatemia and ensuring an adequate circuit life, also avoiding electrolyte and acid-base derangements.
- Being tested
- Renal Replacement Therapy (RRT) start
- Keywords
- Acute kidney injury, Regional citrate anticoagulation, Continuous renal replacement therapy, Prolonged intermittent renal replacement therapy
- Medical subject headings
- Acute Kidney Injury, Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Replacement Therapy (RRT) startOther
At the discretion of the nephrologist, treatment modality will be selected among CVVH, CVVHDF or SLED. Whatever the RRT modality, the investigators will adopt RCA as the standard anticoagulation strategy
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypophosphatemia
Occurrence of hypophosphatemia during the first 72 hours of continuous renal replacement therapy (CRRT) or sustained low-efficiency dialysis (SLED)
Measured: 72 hours
Acid-base derangements
Occurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol
Measured: 72 hours
Variations of RCA-RRT parameters
Evaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings
Measured: 72 hours
Variations of RCA-RRT solutions
Evaluation of the need for variations in RRT solutions flow rate rom initial RRT settings
Measured: 72 hours
Secondary outcomes (2)
Hypomagnesemia
Occurrence of hypomagnesemia during the first 72 hours of CRRT or SLED
Measured: 72 hours
Efficacy of RCA
Efficacy of RCA in terms of circuit lifetime and filter efficiency
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jun 2019
- Primary completion1 Jun 2019
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Fiaccadori, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976440
- Sponsor's protocol ID
- CRRT/SLED-RCA protocol
- Status last verified
- Jun 2019
- First submitted
- 29 May 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fliser D, Kielstein JT. Technology Insight: treatment of renal failure in the intensive care unit with extended dialysis. Nat Clin Pract Nephrol. 2006 Jan;2(1):32-9. doi: 10.1038/ncpneph0060.
PubMed 16932387VA/NIH Acute Renal Failure Trial Network; Palevsky PM, Zhang JH, O'Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RM, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P. Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med. 2008 Jul 3;359(1):7-20. doi: 10.1056/NEJMoa0802639. Epub 2008 May 20.
PubMed 18492867Mariano F, Pozzato M, Canepari G, Vitale C, Bermond F, Sacco C, Amore A, Manes M, Navino C; Piedmont and Aosta Valley Section of Italian Society of Nephrology. Renal replacement therapy in intensive care units: a survey of nephrological practice in northwest Italy. J Nephrol. 2011 Mar-Apr;24(2):165-76. doi: 10.5301/jn.2010.2380.
PubMed 20586025Marshall MR, Golper TA. Low-efficiency acute renal replacement therapy: role in acute kidney injury. Semin Dial. 2011 Mar-Apr;24(2):142-8. doi: 10.1111/j.1525-139X.2011.00829.x.
PubMed 21517979Marshall MR, Creamer JM, Foster M, Ma TM, Mann SL, Fiaccadori E, Maggiore U, Richards B, Wilson VL, Williams AB, Rankin AP. Mortality rate comparison after switching from continuous to prolonged intermittent renal replacement for acute kidney injury in three intensive care units from different countries. Nephrol Dial Transplant. 2011 Jul;26(7):2169-75. doi: 10.1093/ndt/gfq694. Epub 2010 Nov 12.
PubMed 21075821Schwenger V, Weigand MA, Hoffmann O, Dikow R, Kihm LP, Seckinger J, Miftari N, Schaier M, Hofer S, Haar C, Nawroth PP, Zeier M, Martin E, Morath C. Sustained low efficiency dialysis using a single-pass batch system in acute kidney injury - a randomized interventional trial: the REnal Replacement Therapy Study in Intensive Care Unit PatiEnts. Crit Care. 2012 Jul 27;16(4):R140. doi: 10.1186/cc11445.
PubMed 22839577Fieghen HE, Friedrich JO, Burns KE, Nisenbaum R, Adhikari NK, Hladunewich MA, Lapinsky SE, Richardson RM, Wald R; University of Toronto Acute Kidney Injury Research Group. The hemodynamic tolerability and feasibility of sustained low efficiency dialysis in the management of critically ill patients with acute kidney injury. BMC Nephrol. 2010 Nov 25;11:32. doi: 10.1186/1471-2369-11-32.
PubMed 21106112Kron J, Kron S, Wenkel R, Schuhmacher HU, Thieme U, Leimbach T, Kern H, Neumayer HH, Slowinski T. Extended daily on-line high-volume haemodiafiltration in septic multiple organ failure: a well-tolerated and feasible procedure. Nephrol Dial Transplant. 2012 Jan;27(1):146-52. doi: 10.1093/ndt/gfr269. Epub 2011 May 28.
PubMed 21622989Kielstein JT, Kretschmer U, Ernst T, Hafer C, Bahr MJ, Haller H, Fliser D. Efficacy and cardiovascular tolerability of extended dialysis in critically ill patients: a randomized controlled study. Am J Kidney Dis. 2004 Feb;43(2):342-9. doi: 10.1053/j.ajkd.2003.10.021.
PubMed 14750100Fiaccadori E, Maggiore U, Parenti E, Giacosa R, Picetti E, Rotelli C, Tagliavini D, Cabassi A. Sustained low-efficiency dialysis (SLED) with prostacyclin in critically ill patients with acute renal failure. Nephrol Dial Transplant. 2007 Feb;22(2):529-37. doi: 10.1093/ndt/gfl627. Epub 2006 Oct 28.
PubMed 17071958Fiaccadori E, Regolisti G, Cademartiri C, Cabassi A, Picetti E, Barbagallo M, Gherli T, Castellano G, Morabito S, Maggiore U. Efficacy and safety of a citrate-based protocol for sustained low-efficiency dialysis in AKI using standard dialysis equipment. Clin J Am Soc Nephrol. 2013 Oct;8(10):1670-8. doi: 10.2215/CJN.00510113. Epub 2013 Aug 29.
PubMed 23990164Morabito S, Pistolesi V, Tritapepe L, Fiaccadori E. Regional citrate anticoagulation for RRTs in critically ill patients with AKI. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2173-88. doi: 10.2215/CJN.01280214. Epub 2014 Jul 3.
PubMed 24993448Fiaccadori E, Maggiore U, Clima B, Melfa L, Rotelli C, Borghetti A. Incidence, risk factors, and prognosis of gastrointestinal hemorrhage complicating acute renal failure. Kidney Int. 2001 Apr;59(4):1510-9. doi: 10.1046/j.1523-1755.2001.0590041510.x.
PubMed 11260415Fiaccadori E, Pistolesi V, Mariano F, Mancini E, Canepari G, Inguaggiato P, Pozzato M, Morabito S. Regional citrate anticoagulation for renal replacement therapies in patients with acute kidney injury: a position statement of the Work Group "Renal Replacement Therapies in Critically Ill Patients" of the Italian Society of Nephrology. J Nephrol. 2015 Apr;28(2):151-64. doi: 10.1007/s40620-014-0160-2. Epub 2015 Jan 14.
PubMed 25585821Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012 Aug 25;380(9843):756-66. doi: 10.1016/S0140-6736(11)61454-2. Epub 2012 May 21.
PubMed 22617274
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Regional Citrate Anticoagulation Protocols for CVVH, CVVHDF and SLED Focused on the Prevention of RRT-related Hypophosphatemia and Optimization of Acid-base Balance: a Pilot Study
- ClinicalTrials.gov ID
- NCT03976440
- Acronym / sponsor ID
- CRRT/SLED-RCA protocol
- Keywords
- Acute kidney injury, Regional citrate anticoagulation, Continuous renal replacement therapy, Prolonged intermittent renal replacement therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 6 Jun 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.
The aim of the study are: 1) To evaluate the occurrence of acid-base alterations and the incidence of hypophosphatemia during different modalities of Renal Replacement Terapy (RRT) in critically ill patients [CVVH, CVVHDF and SLED (Sustained Low-Efficiency Dialysis)] by using a simplified Regional Citrate Anticoagulation (RCA) protocol combined with the adoption of a phosphate-containing solution as dialysate and/or replacement fluid; 2) To optimize the infusion rates of different solutions adopted, including citrate, in order to obtain an appropriate electrolyte and buffer supply. The final aim of this approach will be to reduce the need for frequent monitoring of acid-base status and electrolytes (with special regard to ionized calcium levels), and to avoid the need for frequent adjustments of RCA-RRT parameters (infusion rate of different solutions, electrolytes supplementation in the course of RRT). This approach could allow to simplify anticoagulation protocols with citrate, in order to minimize potential concerns hampering a wider diffusion of RCA in daily practice.
Detailed description
The need for continuous anticoagulation represents a potential drawback of RRT modalities. KDIGO 2012 guidelines on acute kidney injury (AKI) suggest the adoption of RCA as first choice anticoagulation modality for continuous RRT (CRRT) in patients without contraindications for citrate. Citrate has been also introduced as anticoagulant for SLED and its use in the context of a mainly diffusive prolonged intermittent modality has been shown to represent an easy and safe method to maintain the extracorporeal circuit when concentrated citrate solutions, such as ACD-A are used. Hypophosphatemia is a known issue of RRT, and has been reported in up to 50-80% of cases when standard RRT solutions are used, especially in continuous/prolonged intermitted modalities when high RRT doses are delivered. RRT-related phosphate depletion should be avoided in critically ill patients due to the relevant hypophosphatemia-associated complications in this clinical setting. The adoption of phosphate-containing CRRT solutions could reduce the incidence of hypophosphatemia and minimize the need for parenteral phosphorus supplementation.The adoption of a commercially available phosphate-containing CRRT solution, in the setting of RCA-RRT may allow to meet the double target of minimizing RRT-induced hypophosphatemia and ensuring an adequate circuit life, also avoiding electrolyte and acid-base derangements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients aged >=18 years with severe acute kidney injury (AKI) or end stage renal disease (ESRD) requiring renal replacement therapy
Key inclusion criteria (3 listed)
- age >= 18 years
- critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for severe acute kidney injury (AKI)
- critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for end stage renal disease (ESRD)
Key exclusion criteria (1 listed)
- age < 18 years
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 |
|---|---|---|
| Renal Replacement Therapy (RRT) startAt the discretion of the nephrologist, treatment modality will be selected among CVVH, CVVHDF or SLED. Whatever the RRT modality, the investigators will adopt RCA as the standard anticoagulation strategy | Other | – |
Primary outcome
Hypophosphatemia
Time frame: 72 hours
Occurrence of hypophosphatemia during the first 72 hours of continuous renal replacement therapy (CRRT) or sustained low-efficiency dialysis (SLED)
Acid-base derangements
Time frame: 72 hours
Occurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol
Variations of RCA-RRT parameters
Time frame: 72 hours
Evaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings
Variations of RCA-RRT solutions
Time frame: 72 hours
Evaluation of the need for variations in RRT solutions flow rate rom initial RRT settings
2 secondary outcomes
Hypomagnesemia
Time frame: 72 hours
Efficacy of RCA
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Results publication: PubMed 16932387Fliser D, Kielstein JT. Technology Insight: treatment of renal failure in the intensive care unit with extended dialysis. Nat Clin Pract Nephrol. 2006 Jan;2(1):32-9. doi: 10.1038/ncpneph0060.
- Results publication: PubMed 18492867VA/NIH Acute Renal Failure Trial Network; Palevsky PM, Zhang JH, O'Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RM, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P. Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med. 2008 Jul 3;359(1):7-20. doi: 10.1056/NEJMoa0802639. Epub 2008 May 20.
- Results publication: PubMed 20586025Mariano F, Pozzato M, Canepari G, Vitale C, Bermond F, Sacco C, Amore A, Manes M, Navino C; Piedmont and Aosta Valley Section of Italian Society of Nephrology. Renal replacement therapy in intensive care units: a survey of nephrological practice in northwest Italy. J Nephrol. 2011 Mar-Apr;24(2):165-76. doi: 10.5301/jn.2010.2380.
- Results publication: PubMed 21517979Marshall MR, Golper TA. Low-efficiency acute renal replacement therapy: role in acute kidney injury. Semin Dial. 2011 Mar-Apr;24(2):142-8. doi: 10.1111/j.1525-139X.2011.00829.x.
- Results publication: PubMed 21075821Marshall MR, Creamer JM, Foster M, Ma TM, Mann SL, Fiaccadori E, Maggiore U, Richards B, Wilson VL, Williams AB, Rankin AP. Mortality rate comparison after switching from continuous to prolonged intermittent renal replacement for acute kidney injury in three intensive care units from different countries. Nephrol Dial Transplant. 2011 Jul;26(7):2169-75. doi: 10.1093/ndt/gfq694. Epub 2010 Nov 12.
- Results publication: PubMed 22839577Schwenger V, Weigand MA, Hoffmann O, Dikow R, Kihm LP, Seckinger J, Miftari N, Schaier M, Hofer S, Haar C, Nawroth PP, Zeier M, Martin E, Morath C. Sustained low efficiency dialysis using a single-pass batch system in acute kidney injury - a randomized interventional trial: the REnal Replacement Therapy Study in Intensive Care Unit PatiEnts. Crit Care. 2012 Jul 27;16(4):R140. doi: 10.1186/cc11445.
- Results publication: PubMed 21106112Fieghen HE, Friedrich JO, Burns KE, Nisenbaum R, Adhikari NK, Hladunewich MA, Lapinsky SE, Richardson RM, Wald R; University of Toronto Acute Kidney Injury Research Group. The hemodynamic tolerability and feasibility of sustained low efficiency dialysis in the management of critically ill patients with acute kidney injury. BMC Nephrol. 2010 Nov 25;11:32. doi: 10.1186/1471-2369-11-32.
- Results publication: PubMed 21622989Kron J, Kron S, Wenkel R, Schuhmacher HU, Thieme U, Leimbach T, Kern H, Neumayer HH, Slowinski T. Extended daily on-line high-volume haemodiafiltration in septic multiple organ failure: a well-tolerated and feasible procedure. Nephrol Dial Transplant. 2012 Jan;27(1):146-52. doi: 10.1093/ndt/gfr269. Epub 2011 May 28.
- Results publication: PubMed 14750100Kielstein JT, Kretschmer U, Ernst T, Hafer C, Bahr MJ, Haller H, Fliser D. Efficacy and cardiovascular tolerability of extended dialysis in critically ill patients: a randomized controlled study. Am J Kidney Dis. 2004 Feb;43(2):342-9. doi: 10.1053/j.ajkd.2003.10.021.
- Results publication: PubMed 17071958Fiaccadori E, Maggiore U, Parenti E, Giacosa R, Picetti E, Rotelli C, Tagliavini D, Cabassi A. Sustained low-efficiency dialysis (SLED) with prostacyclin in critically ill patients with acute renal failure. Nephrol Dial Transplant. 2007 Feb;22(2):529-37. doi: 10.1093/ndt/gfl627. Epub 2006 Oct 28.
- Results publication: PubMed 23990164Fiaccadori E, Regolisti G, Cademartiri C, Cabassi A, Picetti E, Barbagallo M, Gherli T, Castellano G, Morabito S, Maggiore U. Efficacy and safety of a citrate-based protocol for sustained low-efficiency dialysis in AKI using standard dialysis equipment. Clin J Am Soc Nephrol. 2013 Oct;8(10):1670-8. doi: 10.2215/CJN.00510113. Epub 2013 Aug 29.
- Results publication: PubMed 24993448Morabito S, Pistolesi V, Tritapepe L, Fiaccadori E. Regional citrate anticoagulation for RRTs in critically ill patients with AKI. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2173-88. doi: 10.2215/CJN.01280214. Epub 2014 Jul 3.
- KDIGO Clinical Practice Guideline for Acute Kidney InjuryLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Failure and Dialysis Related Complication, run by University of Parma at 1 site in Italy.
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 3 inclusion and 1 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 24 Jul 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 Italy. 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?
Results are not available in the source record.
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?
Hypophosphatemia (time frame: 72 hours). The study lists 4 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 NCT03976440, which also lists 54 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 24 Jul 2019.