End-stage Renal Disease (ESRD)HDRRFI-NIRSNCT06243900
NIRS for the Diagnosis of Residual Renal Function Injury in Hemodialysis Patients
An observational study of End-stage Renal Disease (ESRD), run by Yuanjun Yang at 1 site in China.
Trial summary
Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease (ESRD), accounting for approximately 69% of all renal replacement therapies and 89% of all dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease (ESRD)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 14 Feb 2026
- 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: Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
Who may be able to join
- Age ≥ 18 years;
- Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
- Urine output > 500ml/day or GFR > 3ml/min/1.72m2;
- Signed and dated informed consented is obtained.
Who cannot join
- Presence of vascular access dysfunction (blood flow rate < 180ml/min);
- COPD or blood oxygen saturation < 95%;
- Severe heart failure;
- Active infection;
- Infectious disease;
- Distance between the kidney and body surface > 4cm;
Show all 14Show fewer
- Severe pigmentation or skin lesions in the renal area;
- Patients with severe anemia;
- Patients with polycystic kidney disease;
- Expected dialysis duration < 6 months;
- Pregnancy or lactation women;
- Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
- Unwillingness to be followed up or poor adherence to treatment;
- Other circumstances that the investigator considers unsuitable for enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NIRS: a Tool for the Diagnosis of Residual Renal Function Injury in Hemodialysis Patients
Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease (ESRD), accounting for approximately 69% of all renal replacement therapies and 89% of all dialysis. However, factors such as unstable hemodynamics have led to the gradual loss of residual renal function (RRF) in HD patients, which not only affects the adequacy of dialysis and complications control but also impacts their quality of life and survival. Unfortunately, until now, there have been no effective methods for early diagnosis and prediction of residual renal injury, and by the time it was discovered, the opportunity for effective treatment had been missed. The purpose of this study is to validate the value of near-infrared spectroscopy (NIRS) in the early diagnosis and prediction of residual renal injury. This will provide a basis for the application of NIRS in the early monitoring of residual renal injury in HD patients and offer a new method and perspective for the early diagnosis of residual renal injury in HD patients.
Read the detailed description
Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease (ESRD), accounting for approximately 69% of all renal replacement therapies and 89% of all dialysis. However, factors such as unstable hemodynamics have led to the gradual loss of residual renal function (RRF) in HD patients. Research has found that 25%-67% of HD patients progress to anuria within the first 10 months of starting dialysis. The rate of loss is much faster than peritoneal dialysis（PD）, and the more frequent the dialysis sessions, the faster the loss of RRF. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patient's quality of life and survival. Unfortunately, until now, there have been no effective methods for early diagnosis and prediction of residual renal injury.
Traditionally, monitoring and diagnosing kidney damage have relied mainly on serum creatinine, urine output, and estimated glomerular filtration rate (eGFR). However, these indicators often occur after kidney damage has occurred, and their detection is delayed. The sensitivity for early diagnosis of kidney injury is low. By the time abnormalities are detected, the crucial treatment opportunity may have been missed. In addition, serum creatinine and other tests are susceptible to factors such as fluid dilution and reduced production in the body. Although some biomarkers for early diagnosis of acute kidney injury (AKI) have been developed domestically and internationally, most of them have not been applied in clinical practice and cannot be monitored in real-time. Moreover, these biomarkers may have significant differences in their generation between AKI and end-stage renal disease (ESRD) patients, making them unsuitable for early diagnosis and monitoring of residual renal injury in HD patients.
Near-infrared spectroscopy (NIRS) is a simple, safe, non-invasive, and real-time detection method that reflects organ perfusion by measuring changes in regional oxygen saturation. It is widely used in the diagnosis and prediction of neurological disorders, early prediction of AKI related to surgical procedures (cardiovascular, digestive, neurological, etc.), and monitoring of renal perfusion function after kidney transplantation. In theory, it can also be used for early diagnosis of residual renal injury in HD patients. This study is an exploratory research aiming to validate the value of NIRS in early diagnosis of residual renal injury by analyzing the correlation between renal oxygen saturation and urine output, as well as eGFR.
- Conditions
- End-stage Renal Disease (ESRD)
- Keywords
- Hemodialysis, residual renal function, near-infrared spectroscopy
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the renal cerebral oxygen saturation
Measured by Near Infrared Spectroscopy
Measured: 10 months
time to anuria
defined as ≤100 ml/d or ≤200 ml of urine volume in the short interdialytic period
Measured: 10 months
residual renal function (RRF)
The RRF was calculated from an interdialytic urine collection and pre- and post-dialysate blood samples as the mean of the urea and creatinine clearances adjusted for body surface area using a "GFR calculator"
Measured: 10 months
Secondary outcomes (7)
serum creatinine
Taking a blood test to evaluation creatinine
Measured: 10 months
serum urea nitrogen
Taking a blood test to evaluation urea nitrogen
Measured: 10 months
C-reactive protein (CRP)
Taking a blood test to evaluation CRP
Measured: 10 months
Interleukin-6
Taking a blood test to evaluation Interleukin-6
Measured: 10 months
TFF3
Taking a urine test to evaluation TFF3
Measured: 10 months
KIM-1
Taking a urine test to evaluation KIM-1
Measured: 10 months
IP-10
Taking a urine test to evaluation IP-10
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion14 Feb 2026 (estimated)
- Study completion14 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal Disease (ESRD)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuanjun Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanjun Yang, Chinese PLA General Hospital
- Investigators
- Guangyan Cai, PhD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243900
- Sponsor's protocol ID
- S2023-439-01
- Acronym
- HDRRFI-NIRS
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koyner JL, Vaidya VS, Bennett MR, Ma Q, Worcester E, Akhter SA, Raman J, Jeevanandam V, O'Connor MF, Devarajan P, Bonventre JV, Murray PT. Urinary biomarkers in the clinical prognosis and early detection of acute kidney injury. Clin J Am Soc Nephrol. 2010 Dec;5(12):2154-65. doi: 10.2215/CJN.00740110. Epub 2010 Aug 26.
PubMed 20798258Hayek SS, Landsittel DP, Wei C, Zeier M, Yu ASL, Torres VE, Roth S, Pao CS, Reiser J. Soluble Urokinase Plasminogen Activator Receptor and Decline in Kidney Function in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2019 Jul;30(7):1305-1313. doi: 10.1681/ASN.2018121227. Epub 2019 Jun 6.
PubMed 31171572Bello AK, Okpechi IG, Osman MA, Cho Y, Htay H, Jha V, Wainstein M, Johnson DW. Epidemiology of haemodialysis outcomes. Nat Rev Nephrol. 2022 Jun;18(6):378-395. doi: 10.1038/s41581-022-00542-7. Epub 2022 Feb 22.
PubMed 35194215Ogata K. Clinicopathological study of kidneys from patients on chronic dialysis. Kidney Int. 1990 May;37(5):1333-40. doi: 10.1038/ki.1990.119.
PubMed 2345429Rottembourg J. Residual renal function and recovery of renal function in patients treated by CAPD. Kidney Int Suppl. 1993 Feb;40:S106-10. No abstract available.
PubMed 8445831Moist LM, Port FK, Orzol SM, Young EW, Ostbye T, Wolfe RA, Hulbert-Shearon T, Jones CA, Bloembergen WE. Predictors of loss of residual renal function among new dialysis patients. J Am Soc Nephrol. 2000 Mar;11(3):556-564. doi: 10.1681/ASN.V113556.
PubMed 10703680Misra M, Vonesh E, Van Stone JC, Moore HL, Prowant B, Nolph KD. Effect of cause and time of dropout on the residual GFR: a comparative analysis of the decline of GFR on dialysis. Kidney Int. 2001 Feb;59(2):754-63. doi: 10.1046/j.1523-1755.2001.059002754.x.
PubMed 11168959Jansen MA, Hart AA, Korevaar JC, Dekker FW, Boeschoten EW, Krediet RT; NECOSAD Study Group. Predictors of the rate of decline of residual renal function in incident dialysis patients. Kidney Int. 2002 Sep;62(3):1046-53. doi: 10.1046/j.1523-1755.2002.00505.x.
PubMed 12164889Teruel-Briones JL, Fernandez-Lucas M, Rivera-Gorrin M, Ruiz-Roso G, Diaz-Dominguez M, Rodriguez-Mendiola N, Quereda-Rodriguez-Navarro C. Progression of residual renal function with an increase in dialysis: haemodialysis versus peritoneal dialysis. Nefrologia. 2013;33(5):640-9. doi: 10.3265/Nefrologia.pre2013.May.12038. English, Spanish.
PubMed 24089155Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23.
PubMed 23344474Obi Y, Streja E, Rhee CM, Ravel V, Amin AN, Cupisti A, Chen J, Mathew AT, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Incremental Hemodialysis, Residual Kidney Function, and Mortality Risk in Incident Dialysis Patients: A Cohort Study. Am J Kidney Dis. 2016 Aug;68(2):256-265. doi: 10.1053/j.ajkd.2016.01.008. Epub 2016 Feb 9.
PubMed 26867814Wong J, Vilar E, Davenport A, Farrington K. Incremental haemodialysis. Nephrol Dial Transplant. 2015 Oct;30(10):1639-48. doi: 10.1093/ndt/gfv231. Epub 2015 Jun 1.
PubMed 26038351Bargman JM, Golper TA. The importance of residual renal function for patients on dialysis. Nephrol Dial Transplant. 2005 Apr;20(4):671-3. doi: 10.1093/ndt/gfh723. Epub 2005 Mar 8. No abstract available.
PubMed 15755759Wang AY, Lai KN. The importance of residual renal function in dialysis patients. Kidney Int. 2006 May;69(10):1726-32. doi: 10.1038/sj.ki.5000382.
PubMed 16612329Bragg-Gresham JL, Fissell RB, Mason NA, Bailie GR, Gillespie BW, Wizemann V, Cruz JM, Akiba T, Kurokawa K, Ramirez S, Young EW. Diuretic use, residual renal function, and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Pattern Study (DOPPS). Am J Kidney Dis. 2007 Mar;49(3):426-31. doi: 10.1053/j.ajkd.2006.12.012.
PubMed 17336704
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRS: a Tool for the Diagnosis of Residual Renal Function Injury in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06243900
- Acronym / sponsor ID
- HDRRFI-NIRS / S2023-439-01
- Conditions
- End-stage Renal Disease (ESRD)
- Keywords
- Hemodialysis, residual renal function, near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yuanjun YangUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 14 Feb 2026 (estimated)
- First posted
- 6 Feb 2024 (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.
Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease (ESRD), accounting for approximately 69% of all renal replacement therapies and 89% of all dialysis. However, factors such as unstable hemodynamics have led to the gradual loss of residual renal function (RRF) in HD patients, which not only affects the adequacy of dialysis and complications control but also impacts their quality of life and survival. Unfortunately, until now, there have been no effective methods for early diagnosis and prediction of residual renal injury, and by the time it was discovered, the opportunity for effective treatment had been missed. The purpose of this study is to validate the value of near-infrared spectroscopy (NIRS) in the early diagnosis and prediction of residual renal injury. This will provide a basis for the application of NIRS in the early monitoring of residual renal injury in HD patients and offer a new method and perspective for the early diagnosis of residual renal injury in HD patients.
Detailed description
Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease (ESRD), accounting for approximately 69% of all renal replacement therapies and 89% of all dialysis. However, factors such as unstable hemodynamics have led to the gradual loss of residual renal function (RRF) in HD patients. Research has found that 25%-67% of HD patients progress to anuria within the first 10 months of starting dialysis. The rate of loss is much faster than peritoneal dialysis（PD）, and the more frequent the dialysis sessions, the faster the loss of RRF. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patient's quality of life and survival. Unfortunately, until now, there have been no effective methods for early diagnosis and prediction of residual renal injury.
Traditionally, monitoring and diagnosing kidney damage have relied mainly on serum creatinine, urine output, and estimated glomerular filtration rate (eGFR). However, these indicators often occur after kidney damage has occurred, and their detection is delayed. The sensitivity for early diagnosis of kidney injury is low. By the time abnormalities are detected, the crucial treatment opportunity may have been missed. In addition, serum creatinine and other tests are susceptible to factors such as fluid dilution and reduced production in the body. Although some biomarkers for early diagnosis of acute kidney injury (AKI) have been developed domestically and internationally, most of them have not been applied in clinical practice and cannot be monitored in real-time. Moreover, these biomarkers may have significant differences in their generation between AKI and end-stage renal disease (ESRD) patients, making them unsuitable for early diagnosis and monitoring of residual renal injury in HD patients.
Near-infrared spectroscopy (NIRS) is a simple, safe, non-invasive, and real-time detection method that reflects organ perfusion by measuring changes in regional oxygen saturation. It is widely used in the diagnosis and prediction of neurological disorders, early prediction of AKI related to surgical procedures (cardiovascular, digestive, neurological, etc.), and monitoring of renal perfusion function after kidney transplantation. In theory, it can also be used for early diagnosis of residual renal injury in HD patients. This study is an exploratory research aiming to validate the value of NIRS in early diagnosis of residual renal injury by analyzing the correlation between renal oxygen saturation and urine output, as well as eGFR.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Clinical diagnosis of end-stage renal disease requiring long-term hemodialysis treatment, with dialysis duration ≤ 3 months;
- Urine output > 500ml/day or GFR > 3ml/min/1.72m2;
- Signed and dated informed consented is obtained.
Key exclusion criteria (14 listed)
- Presence of vascular access dysfunction (blood flow rate < 180ml/min);
- COPD or blood oxygen saturation < 95%;
- Severe heart failure;
- Active infection;
- Infectious disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the renal cerebral oxygen saturation
Time frame: 10 months
Measured by Near Infrared Spectroscopy
time to anuria
Time frame: 10 months
defined as ≤100 ml/d or ≤200 ml of urine volume in the short interdialytic period
residual renal function (RRF)
Time frame: 10 months
The RRF was calculated from an interdialytic urine collection and pre- and post-dialysate blood samples as the mean of the urea and creatinine clearances adjusted for body surface area using a "GFR calculator"
7 secondary outcomes
serum creatinine
Time frame: 10 months
serum urea nitrogen
Time frame: 10 months
C-reactive protein (CRP)
Time frame: 10 months
Interleukin-6
Time frame: 10 months
TFF3
Time frame: 10 months
KIM-1
Time frame: 10 months
IP-10
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 20798258Koyner JL, Vaidya VS, Bennett MR, Ma Q, Worcester E, Akhter SA, Raman J, Jeevanandam V, O'Connor MF, Devarajan P, Bonventre JV, Murray PT. Urinary biomarkers in the clinical prognosis and early detection of acute kidney injury. Clin J Am Soc Nephrol. 2010 Dec;5(12):2154-65. doi: 10.2215/CJN.00740110. Epub 2010 Aug 26.
- Background: PubMed 31171572Hayek SS, Landsittel DP, Wei C, Zeier M, Yu ASL, Torres VE, Roth S, Pao CS, Reiser J. Soluble Urokinase Plasminogen Activator Receptor and Decline in Kidney Function in Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2019 Jul;30(7):1305-1313. doi: 10.1681/ASN.2018121227. Epub 2019 Jun 6.
- Background: PubMed 35194215Bello AK, Okpechi IG, Osman MA, Cho Y, Htay H, Jha V, Wainstein M, Johnson DW. Epidemiology of haemodialysis outcomes. Nat Rev Nephrol. 2022 Jun;18(6):378-395. doi: 10.1038/s41581-022-00542-7. Epub 2022 Feb 22.
- Background: PubMed 2345429Ogata K. Clinicopathological study of kidneys from patients on chronic dialysis. Kidney Int. 1990 May;37(5):1333-40. doi: 10.1038/ki.1990.119.
- Background: PubMed 8445831Rottembourg J. Residual renal function and recovery of renal function in patients treated by CAPD. Kidney Int Suppl. 1993 Feb;40:S106-10. No abstract available.
- Background: PubMed 10703680Moist LM, Port FK, Orzol SM, Young EW, Ostbye T, Wolfe RA, Hulbert-Shearon T, Jones CA, Bloembergen WE. Predictors of loss of residual renal function among new dialysis patients. J Am Soc Nephrol. 2000 Mar;11(3):556-564. doi: 10.1681/ASN.V113556.
- Background: PubMed 11168959Misra M, Vonesh E, Van Stone JC, Moore HL, Prowant B, Nolph KD. Effect of cause and time of dropout on the residual GFR: a comparative analysis of the decline of GFR on dialysis. Kidney Int. 2001 Feb;59(2):754-63. doi: 10.1046/j.1523-1755.2001.059002754.x.
- Background: PubMed 12164889Jansen MA, Hart AA, Korevaar JC, Dekker FW, Boeschoten EW, Krediet RT; NECOSAD Study Group. Predictors of the rate of decline of residual renal function in incident dialysis patients. Kidney Int. 2002 Sep;62(3):1046-53. doi: 10.1046/j.1523-1755.2002.00505.x.
- Background: PubMed 24089155Teruel-Briones JL, Fernandez-Lucas M, Rivera-Gorrin M, Ruiz-Roso G, Diaz-Dominguez M, Rodriguez-Mendiola N, Quereda-Rodriguez-Navarro C. Progression of residual renal function with an increase in dialysis: haemodialysis versus peritoneal dialysis. Nefrologia. 2013;33(5):640-9. doi: 10.3265/Nefrologia.pre2013.May.12038. English, Spanish.
- Background: PubMed 23344474Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23.
- Background: PubMed 26867814Obi Y, Streja E, Rhee CM, Ravel V, Amin AN, Cupisti A, Chen J, Mathew AT, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Incremental Hemodialysis, Residual Kidney Function, and Mortality Risk in Incident Dialysis Patients: A Cohort Study. Am J Kidney Dis. 2016 Aug;68(2):256-265. doi: 10.1053/j.ajkd.2016.01.008. Epub 2016 Feb 9.
- Background: PubMed 26038351Wong J, Vilar E, Davenport A, Farrington K. Incremental haemodialysis. Nephrol Dial Transplant. 2015 Oct;30(10):1639-48. doi: 10.1093/ndt/gfv231. Epub 2015 Jun 1.
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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.
Guangyan Cai, PhD study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease (ESRD), run by Yuanjun Yang 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 14 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 6 Feb 2024. 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?
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?
Change in the renal cerebral oxygen saturation (time frame: 10 months). 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?
On the ClinicalTrials.gov record for NCT06243900, which also lists 20 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 6 Feb 2024.