A Phase 2 interventional study of Nidufexor and Placebo in Diabetic Nephropathy, sponsored by Novartis Pharmaceuticals. Completed at 18 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
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.
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.
544 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.
This study's enrollment of 83 is close to the median of 80 across 385 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.
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Exclusion Criteria:
50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.
Drug: Nidufexor · Drug: Standard of Care (SoC)
Placebo was orally administered once daily for 24 weeks in addition to SoC.
Other: Placebo · Drug: Standard of Care (SoC)
50 mg (two 25 mg) LMB763 capsules for oral administration
Also known as: LMB763
Placebo capsules for oral administration
Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
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.
Time frame: 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.
Time frame: 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.
Time frame: From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days
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.
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and days 14, 29, 57, 85, 113, 141 and 169
Participants were recruited from 18 sites in 7 countries.
| Milestone | LMB763 | Placebo |
|---|---|---|
| Started | 41 | 42 |
| Pharmacokinetics (pk) analysis set | 41 | 0 |
| Pharmacodynamics (pd) analysis set | 41 | 41 |
| Completed | 25 | 29 |
| Not completed | 16 | 13 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Study terminated by sponsor | 10 | 12 |
| Withdrew: Withdrawal by subject | 3 | 1 |
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 | LMB763 | Placebo |
|---|---|---|
| Day 14 | 0.90 (0.79 to 1.02) | 1.06 (0.94 to 1.20) |
| Day 29 | 0.83 (0.75 to 0.93) | 1.00 (0.90 to 1.12) |
| Day 57 | 0.85 (0.76 to 0.94) | 1.05 (0.95 to 1.17) |
| Day 85 | 0.84 (0.72 to 0.97) | 1.07 (0.93 to 1.23) |
| Day 113 | 0.87 (0.73 to 1.04) | 1.07 (0.90 to 1.26) |
| Day 141 | 0.84 (0.71 to 1.01) | 1.15 (0.98 to 1.35) |
| Day 169 | 0.74 (0.61 to 0.89) | 0.92 (0.78 to 1.10) |
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.
| Ratio to baseline | LMB763 | Placebo |
|---|---|---|
| Ratio to Baseline in 24 Hour Urinary Albumin at Week 24 (Day 169) | 0.58 (0.45 to 0.74) | 0.91 (0.72 to 1.14) |
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.
| Participants | LMB763 | Placebo |
|---|---|---|
| AEs | 29 | 25 |
| SAEs | 2 | 2 |
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.
| Ratio | LMB763 | Placebo |
|---|---|---|
| Day 14 | 0.95 (0.93 to 0.98) | 0.96 (0.94 to 0.99) |
| Day 29 | 0.94 (0.91 to 0.97) | 0.94 (0.91 to 0.97) |
| Day 57 | 0.98 (0.95 to 1.02) | 0.96 (0.93 to 1.00) |
| Day 85 | 0.97 (0.93 to 1.01) | 0.94 (0.90 to 0.97) |
| Day 113 | 0.96 (0.92 to 0.99) | 0.94 (0.91 to 0.98) |
| Day 141 | 0.98 (0.95 to 1.02) | 0.93 (0.90 to 0.96) |
| Day 169 | 0.93 (0.89 to 0.97) | 0.93 (0.90 to 0.97) |
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.
| Nanogram/milliliter | LMB763 |
|---|---|
| Day 1 | 1090 ± 665 |
| Day 14 | 1300 ± 691 |
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.
| Hour | LMB763 |
|---|---|
| Day 1 | 3.25 (0.75 to 6) |
| Day 14 | 2 (0 to 6) |
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.
| Hour*nanogram/milliliter | LMB763 |
|---|---|
| Day 1 | 3710 ± 2510 |
| Day 14 | 4850 ± 2910 |
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.
| Ratio | LMB763 | Placebo |
|---|---|---|
| Ratio to Baseline in Free Water Clearance | 0.97 (0.86 to 1.10) | 0.97 (0.88 to 1.08) |
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.
| Ratio | LMB763 | Placebo |
|---|---|---|
| Ratio to Baseline in Lipoprotein A at Day 85 | 0.72 (0.67 to 0.77) | 0.95 (0.90 to 1.01) |
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.
| Ratio to baseline | LMB763 | Placebo |
|---|---|---|
| Ratio to Baseline in Lipoprotein A at Day 169 | 0.75 (0.66 to 0.85) | 0.89 (0.81 to 0.99) |
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.
| Percent change | LMB763 | Placebo |
|---|---|---|
| Day 14 | -0.08 (-0.45 to 0.29) | -0.13 (-0.50 to 0.23) |
| Day 29 | -0.57 (-0.99 to -0.14) | -0.03 (-0.45 to 0.39) |
| Day 57 | -0.69 (-1.35 to -0.04) | -0.24 (-0.90 to 0.41) |
| Day 85 | -0.41 (-1.21 to 0.38) | 0.08 (-0.70 to 0.86) |
| Day 113 | -0.51 (-1.42 to 0.40) | 0.21 (-0.67 to 1.09) |
| Day 141 | -0.80 (-1.69 to 0.09) | 0.43 (-0.44 to 1.29) |
| Day 169 | -0.61 (-1.60 to 0.39) | 0.55 (-0.38 to 1.47) |
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.
| Percent change | LMB763 | Placebo |
|---|---|---|
| Day 14 | -0.01 (-0.12 to 0.10) | -0.05 (-0.16 to 0.06) |
| Day 29 | -0.19 (-0.32 to -0.05) | -0.02 (-0.15 to 0.12) |
| Day 57 | -0.23 (-0.44 to -0.02) | -0.07 (-0.28 to 0.14) |
| Day 85 | -0.13 (-0.40 to 0.13) | 0.03 (-0.22 to 0.29) |
| Day 113 | -0.18 (-0.47 to 0.12) | 0.07 (-0.21 to 0.35) |
| Day 141 | -0.31 (-0.60 to -0.01) | 0.16 (-0.12 to 0.45) |
| Day 169 | -0.29 (-0.61 to 0.04) | 0.16 (-0.15 to 0.47) |
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.
| Ratio | LMB763 | Placebo |
|---|---|---|
| Day 14 | -0.00 (-0.01 to 0.00) | -0.00 (-0.01 to 0.00) |
| Day 29 | -0.00 (-0.01 to 0.00) | 0.00 (-0.00 to 0.01) |
| Day 57 | -0.00 (-0.01 to 0.00) | 0.00 (-0.01 to 0.01) |
| Day 85 | -0.00 (-0.01 to 0.00) | 0.01 (-0.00 to 0.01) |
| Day 113 | -0.00 (-0.01 to 0.01) | 0.01 (0.00 to 0.02) |
| Day 141 | -0.00 (-0.01 to 0.01) | 0.02 (0.01 to 0.03) |
| Day 169 | -0.00 (-0.01 to 0.01) | -0.00 (-0.01 to 0.00) |
Collected over Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LMB763 | 0/41 (0%) | 2/41 (4.9%) | 28/41 (68.3%) |
| Placebo | 0/42 (0%) | 2/42 (4.8%) | 23/42 (54.8%) |
| Total | 0/83 (0%) | 4/83 (4.8%) | 51/83 (61.4%) |
| Event | LMB763 | Placebo | Total |
|---|---|---|---|
| ErysipelasInfections and infestations | 1/41 | 0/42 | 1/83 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/41 | 0/42 | 1/83 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 1/41 | 0/42 | 1/83 |
| Acute kidney injuryRenal and urinary disorders | 1/41 | 0/42 | 1/83 |
| HypervolaemiaMetabolism and nutrition disorders | 0/41 | 1/42 | 1/83 |
| Renal disorderRenal and urinary disorders | 0/41 | 1/42 | 1/83 |
| Event | LMB763 | Placebo | Total |
|---|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 13/41 | 6/42 | 19/83 |
| Blood creatinine increasedInvestigations | 4/41 | 3/42 | 7/83 |
| HyperglycaemiaMetabolism and nutrition disorders | 3/41 | 2/42 | 5/83 |
| Back painMusculoskeletal and connective tissue disorders | 3/41 | 2/42 | 5/83 |
| Urine albumin/creatinine ratio increasedInvestigations | 0/41 | 3/42 | 3/83 |
| Abdominal pain upperGastrointestinal disorders | 2/41 | 1/42 | 3/83 |
| ConstipationGastrointestinal disorders | 2/41 | 1/42 | 3/83 |
| DiarrhoeaGastrointestinal disorders | 2/41 | 0/42 | 2/83 |
| FatigueGeneral disorders | 2/41 | 0/42 | 2/83 |
| GastroenteritisInfections and infestations | 2/41 | 1/42 | 3/83 |
| Age, Continuous(Years) | LMB763 | Placebo | Total |
|---|---|---|---|
| Mean | 60.8 ± 8.95 | 61.6 ± 8.36 | 61.2 ± 8.61 |
| Sex: Female, Male(Participants) | LMB763 | Placebo | Total |
|---|---|---|---|
| Female | 13 | 10 | 23 |
| Male | 28 | 32 | 60 |
| Race (NIH/OMB)(Participants) | LMB763 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 41 | 41 | 82 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Plan to share: 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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