Diabetic NephropathyPhase 2NCT03804879
Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy
A Phase 2 study testing Nidufexor in people with Diabetic Nephropathy, run by Novartis Pharmaceuticals at 18 sites in 7 countries.
Trial summary
Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Nidufexor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 17 Dec 2018to 3 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female patients, 18-75 years
- Written informed consent
- Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening
- Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at screening while receiving a dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker that is the standard of care as judged by the study doctor.
Who cannot join
- History of type 1 diabetes mellitus
- Severe renal impairment manifesting as serum creatinine eGFR < 30 mL/min/1.73 m^2 at screening
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using basic methods of contraception during dosing of study treatment
- Uncontrolled diabetes mellitus at screening
- History or current diagnosis of ECG abnormalities prior to first study dose
Show all 9Show fewer
- History of kidney disease other than diabetic nephropathy at screening
- Uncontrolled hypertension at screening
- Use of prohibited medications, including but not limited to GLP-1 agonists and SGLT2 inhibitors.
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
United States5 sites
Novartis Investigative Site
Albany, New York, 12206
Novartis Investigative Site
El Paso, Texas, 79935
Novartis Investigative Site
Miami Lakes, Florida, 33014
Novartis Investigative Site
Norman, Oklahoma, 73069
Novartis Investigative Site
Sugar Land, Texas, 77479
Argentina3 sites
Novartis Investigative Site
Buenos Aires, C1120AAC
Novartis Investigative Site
CABA, Buenos Aires, 1407
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ
Germany3 sites
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Elsterwerda, 04910
Novartis Investigative Site
Essen, Nordrhine Westphalia, 45136
Turkey (Türkiye)3 sites
Novartis Investigative Site
Istanbul, TUR, 34098
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Talas / Kayseri, 38039
Lebanon2 sites
Novartis Investigative Site
El Achrafiyé
Novartis Investigative Site
Saida, 652
About this study
Official title: A Randomized Patient-and-physician Blinded, Placebo-controlled, 24-week Study to Assess the Safety, Tolerability and Efficacy of LMB763 in Patients With Diabetic Nephropathy
Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)).
This non-confirmatory Phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes and nephropathy.
Read the detailed description
This was a non-confirmatory, multicenter, patient- and investigator-blinded, randomized, and placebo-controlled, proof-of concept trial assessing nidufexor vs. placebo in patients receiving standard of care (optimal tolerated doses of ARB or ACEI) for diabetic nephropathy due to type 2 diabetes.
The study consisted of three distinct study periods:
Screening (Day -30 to Day-1): lasted up to a maximum of 30 days and comprised a screening / baseline assessment. This visit was used to confirm that the study inclusion and exclusion criteria were met and served as baseline assessment prior to randomization. Participant randomization occurred prior to day 1 as soon as participant eligibility was confirmed.
Treatment period (Day 1-168): Participants were randomized in a 1:1 ratio to receive nidufexor 50 mg or placebo once daily for 24 weeks. Nidufexor and placebo were given in addition to SoC (optimal tolerated doses of ARB or ACEI).
End of Study (EOS) and Safety follow-up (Day 169 to Day 197): Study assessments were performed until the EOS visit (Day 169). Post Study Safety Contact occurred approximately 28 days after discontinuing study treatment until day 197.
- Conditions
- Diabetic Nephropathy
- Being tested
- Nidufexor, Placebo, Standard of Care (SoC)
- Keywords
- diabetes
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NidufexorDrug
Also called LMB763
50 mg (two 25 mg) LMB763 capsules for oral administration
PlaceboOther
Placebo capsules for oral administration
Standard of Care (SoC)Drug
Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
| Study group | Role | What they receive |
|---|---|---|
| LMB763 | Experimental | 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC. Receives: Drug: Nidufexor; Drug: Standard of Care (SoC) |
| Placebo | Placebo comparator | Placebo was orally administered once daily for 24 weeks in addition to SoC. Receives: Other: Placebo; Drug: Standard of Care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR)
UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion.
UACR (mg/mmol) = urine albumin [mg/L] / urine creatinine [mmol/L]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Measured: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Ratio to Baseline in 24 Hour Urinary Albumin at Week 24 (Day 169)
Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Measured: Baseline and day 169
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The category Number of participants with AEs includes also the number of participants with SAEs. The number of participants in each category is reported in the table.
Measured: From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days
Secondary outcomes (10)
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR)
Estimate Glomerular Filtration Rate (GFR) calculates estimated GFR (eGFR) from serum creatinine levels to assess kidney function. eGFR (milliliter/minute) was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement.
Measured: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Maximum Peak Observed Concentration (Cmax) of LMB763
Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods. No methods for imputation of missing data were used.
Measured: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
Time to Reach Maximum Blood Concentrations (Tmax) of LMB763
Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment). No methods for imputation of missing data were used.
Measured: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763
Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUClast was determined using non-compartmental methods. No methods for imputation of missing data were used.
Measured: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
Ratio to Baseline in Free Water Clearance
The free water clearance (mL/min) was calculated using the following formula: (Total Volume (mL) / Elapsed Date \& Time (min)) * (1-24 hr Urine Osmolality (mOsmol/kg)/ Serum Osmolality (mOsmol/kg))
The result of free water clearance was rounded to one decimal place prior to statistical analysis. An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline free water clearance. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement.
Measured: Baseline and day 169
Ratio to Baseline in Lipoprotein A at Day 85
Lipoprotein A (gram/liter) is a component of the lipid profile which is a panel of blood tests used to find abnormalities in lipids. Ratio to baseline in Lipoprotein A was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Measured: Baseline and day 85
Ratio to Baseline in Lipoprotein A at Day 169
Lipoprotein A (gram/liter) is a component of the lipid profile which is a panel of blood tests used to find abnormalities in lipids. Ratio to baseline in Lipoprotein A was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Measured: Baseline and day 169
Percent Change From Baseline in Weight
Change from baseline in weight was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement.
Measured: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Percent Change From Baseline in Body Mass Index (BMI)
BMI was determined by height and weight measurements: Body weight (kg)/ [Height (m)]^2. Change from baseline in BMI was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement.
Measured: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Change From Baseline in Waist-to-hip Ratio
Waist-to-hip ratio was derived using waist circumference and hip circumference, which was measured at the greatest protrusion of the buttocks. Change from baseline in waist-to-hip ratio was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the change from baseline indicates improvement.
Measured: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start17 Dec 2018
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804879
- Sponsor's protocol ID
- CLMB763X2202
- Other IDs
- 2018-002491-40, 2018
- Status last verified
- Aug 2022
- First submitted
- 26 Nov 2018
- Last updated
- 10 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Patient-and-physician Blinded, Placebo-controlled, 24-week Study to Assess the Safety, Tolerability and Efficacy of LMB763 in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03804879
- Acronym / sponsor ID
- CLMB763X2202
- Conditions
- Diabetic Nephropathy
- Keywords
- diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 29 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)).
This non-confirmatory Phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes and nephropathy.
Detailed description
This was a non-confirmatory, multicenter, patient- and investigator-blinded, randomized, and placebo-controlled, proof-of concept trial assessing nidufexor vs. placebo in patients receiving standard of care (optimal tolerated doses of ARB or ACEI) for diabetic nephropathy due to type 2 diabetes.
The study consisted of three distinct study periods:
Screening (Day -30 to Day-1): lasted up to a maximum of 30 days and comprised a screening / baseline assessment. This visit was used to confirm that the study inclusion and exclusion criteria were met and served as baseline assessment prior to randomization. Participant randomization occurred prior to day 1 as soon as participant eligibility was confirmed.
Treatment period (Day 1-168): Participants were randomized in a 1:1 ratio to receive nidufexor 50 mg or placebo once daily for 24 weeks. Nidufexor and placebo were given in addition to SoC (optimal tolerated doses of ARB or ACEI).
End of Study (EOS) and Safety follow-up (Day 169 to Day 197): Study assessments were performed until the EOS visit (Day 169). Post Study Safety Contact occurred approximately 28 days after discontinuing study treatment until day 197.
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 |
|---|---|---|
| LMB763 | Experimental | Drug: Nidufexor, Drug: Standard of Care (SoC)50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC. |
| Placebo | Placebo comparator | Other: Placebo, Drug: Standard of Care (SoC)Placebo was orally administered once daily for 24 weeks in addition to SoC. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male/female patients, 18-75 years
- Written informed consent
- Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening
- Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at screening while receiving a dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker that is the standard of care as judged by the study doctor.
Key exclusion criteria (9 listed)
- History of type 1 diabetes mellitus
- Severe renal impairment manifesting as serum creatinine eGFR < 30 mL/min/1.73 m^2 at screening
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using basic methods of contraception during dosing of study treatment
- Uncontrolled diabetes mellitus at screening
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 |
|---|---|---|
| NidufexorAlso: LMB76350 mg (two 25 mg) LMB763 capsules for oral administration | Drug | LMB763 |
| PlaceboPlacebo capsules for oral administration | Other | Placebo |
| Standard of Care (SoC)Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) | Drug | LMB763, Placebo |
Primary outcome
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR)
Time frame: Baseline and days 14, 29, 57, 85, 113, 141 and 169
UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin [mg/L] / urine creatinine [mmol/L]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Ratio to Baseline in 24 Hour Urinary Albumin at Week 24 (Day 169)
Time frame: Baseline and day 169
Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days
Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The category Number of participants with AEs includes also the number of participants with SAEs. The number of participants in each category is reported in the table.
10 secondary outcomes
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Maximum Peak Observed Concentration (Cmax) of LMB763
Time frame: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
Time to Reach Maximum Blood Concentrations (Tmax) of LMB763
Time frame: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763
Time frame: pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
Ratio to Baseline in Free Water Clearance
Time frame: Baseline and day 169
Ratio to Baseline in Lipoprotein A at Day 85
Time frame: Baseline and day 85
Ratio to Baseline in Lipoprotein A at Day 169
Time frame: Baseline and day 169
Percent Change From Baseline in Weight
Time frame: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Percent Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Change From Baseline in Waist-to-hip Ratio
Time frame: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nidufexor in people with Diabetic Nephropathy, run by Novartis Pharmaceuticals at 18 sites in 7 countries.
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 9 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 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Argentina, Germany, Turkey (Türkiye), Lebanon and 2 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) (time frame: Baseline and days 14, 29, 57, 85, 113, 141 and 169). 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 10 Aug 2022.