Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN) (MERLIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04702997
Recruitment Status : Completed
First Posted : January 11, 2021
Results First Posted : December 1, 2022
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Kidney Diseases
Interventions Drug: Bardoxolone methyl oral capsule
Drug: Placebo oral capsule
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bardoxolone Methyl Placebo
Hide Arm/Group Description Bardoxolone methyl capsules administered orally once daily for 12 weeks at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) Placebo capsules administered orally once-daily for 12 weeks, with sham titration to maintain the blind.
Period Title: Overall Study
Started 39 42
Completed 38 41
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Bardoxolone Methyl Placebo Total
Hide Arm/Group Description Bardoxolone methyl capsules administered orally once daily for 12 weeks at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) Placebo capsules administered orally once daily for 12 weeks, with sham titration to maintain the blind Total of all reporting groups
Overall Number of Baseline Participants 39 42 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 42 participants 81 participants
56.4  (13.5) 59.8  (12.66) 58.2  (13.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 42 participants 81 participants
Female
16
  41.0%
16
  38.1%
32
  39.5%
Male
23
  59.0%
26
  61.9%
49
  60.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 42 participants 81 participants
Hispanic or Latino
17
  43.6%
10
  23.8%
27
  33.3%
Not Hispanic or Latino
22
  56.4%
31
  73.8%
53
  65.4%
Unknown or Not Reported
0
   0.0%
1
   2.4%
1
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 42 participants 81 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   5.1%
0
   0.0%
2
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  10.3%
3
   7.1%
7
   8.6%
White
32
  82.1%
39
  92.9%
71
  87.7%
More than one race
1
   2.6%
0
   0.0%
1
   1.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 42 participants 81 participants
39 42 81
Baseline estimated glomerular filtration rate (eGFR)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m^2
Number Analyzed 39 participants 42 participants 81 participants
36.563  (9.8465) 34.883  (10.1765) 35.692  (9.9921)
[1]
Measure Description: eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
1.Primary Outcome
Title Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12
Hide Description To assess the change in eGFR from baseline to week 12. eGFR is a measure of kidney function assessed through blood/serum. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function.
Time Frame Baseline through 12 weeks after participant receives the first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all enrolled patients whether or not they received the study drug)
Arm/Group Title Bardoxolone Methyl Placebo
Hide Arm/Group Description:
Bardoxolone methyl capsules administered orally once daily for 12 weeks at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g)
Placebo capsules administered orally once daily for 12 weeks, with sham titration to maintain the blind
Overall Number of Participants Analyzed 39 42
Least Squares Mean (Standard Error)
Unit of Measure: mL/min/1.73 m^2
6.79  (0.925) -0.92  (0.868)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bardoxolone Methyl, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments KDIGO strata, treatment group, time (Week 1 to 12), and the interaction between treatment and time were used as fixed factors.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference (Net)
Estimated Value 7.71
Confidence Interval (2-Sided) 95%
5.18 to 10.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.268
Estimation Comments Difference is bardoxolone methyl - placebo
Time Frame 17 weeks
Adverse Event Reporting Description All adverse events that are observed or reported by the patient during the study (from the time of the first dose of study drug until the final visit) must be reported, regardless of their relationship to study drug or their clinical significance.
 
Arm/Group Title Bardoxolone Methyl Placebo
Hide Arm/Group Description Bardoxolone methyl capsules administered orally once daily for 12 weeks at a starting dose of 5 mg and titrated up to a maximal dose of 20 mg (participants with UACR less than or equal to 300 mg/g) or 30 mg (participants with UACR greater than 300 mg/g) Placebo capsules administered orally once daily for 12 weeks, with sham titration to maintain the blind
All-Cause Mortality
Bardoxolone Methyl Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/42 (0.00%)    
Hide Serious Adverse Events
Bardoxolone Methyl Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/39 (7.69%)      1/42 (2.38%)    
Gastrointestinal disorders     
Gastrooesophageal reflux disease  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Small intestinal obstruction  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Hepatobiliary disorders     
Biliary dyskinesia  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/39 (2.56%)  1 0/42 (0.00%)  0
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Bardoxolone Methyl Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/39 (79.49%)      30/42 (71.43%)    
Blood and lymphatic system disorders     
Anaemia  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Cardiac disorders     
Cardiac septal hypertrophy  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Diastolic dysfunction  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Left ventricular hypertrophy  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Mitral valve incompetence  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Pulmonary valve incompetence  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Sinus bradycardia  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Tachycardia  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Tricuspid valve incompetence  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Vertigo  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Eye disorders     
Cataract  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Diabetic retinal oedema  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Diabetic retinopathy  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Glaucoma  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Macular detachment  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Non-proliferative retinopathy  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Gastrointestinal disorders     
Abdominal mass  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Abdominal pain  1  4/39 (10.26%)  4 0/42 (0.00%)  0
Abdominal pain upper  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Constipation  1  3/39 (7.69%)  3 0/42 (0.00%)  0
Diarrhoea  1  5/39 (12.82%)  6 2/42 (4.76%)  2
Dry mouth  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Flatulence  1  1/39 (2.56%)  2 1/42 (2.38%)  1
Gastrooesophageal reflux disease  1  2/39 (5.13%)  2 0/42 (0.00%)  0
Haematochezia  1  0/39 (0.00%)  0 1/42 (2.38%)  2
Nausea  1  6/39 (15.38%)  8 3/42 (7.14%)  4
Stomatitis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Vomiting  1  5/39 (12.82%)  5 2/42 (4.76%)  2
General disorders     
Asthenia  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Chest pain  1  0/39 (0.00%)  0 1/42 (2.38%)  2
Fatigue  1  2/39 (5.13%)  2 1/42 (2.38%)  1
Oedema peripheral  1  2/39 (5.13%)  3 4/42 (9.52%)  4
Pyrexia  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Hepatobiliary disorders     
Hepatic steatosis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Immune system disorders     
Seasonal allergy  1  0/39 (0.00%)  0 1/42 (2.38%)  2
Infections and infestations     
Bronchitis  1  2/39 (5.13%)  2 0/42 (0.00%)  0
Cellulitis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Conjunctivitis  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Corona virus infection  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Furuncle  1  0/39 (0.00%)  0 2/42 (4.76%)  2
Nasopharyngitis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Oral candidiasis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Orchitis  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Otitis media  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Pharyngitis  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Sinusitis  1  2/39 (5.13%)  2 0/42 (0.00%)  0
Skin infection  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Tooth abscess  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Upper respiratory tract infection  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Urinary tract infection  1  2/39 (5.13%)  2 1/42 (2.38%)  1
Injury, poisoning and procedural complications     
Arthropod bite  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Hand fracture  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Ligament sprain  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Procedural pain  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Tendon rupture  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  3/39 (7.69%)  3 0/42 (0.00%)  0
Aspartate aminotransferase increased  1  2/39 (5.13%)  2 0/42 (0.00%)  0
Blood alkaline phosphatase increased  1  2/39 (5.13%)  2 0/42 (0.00%)  0
Blood magnesium decreased  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Blood potassium decreased  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Blood pressure increased  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Brain natriuretic peptide increased  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Cardiac murmur  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Gamma-glutamyltransferase increased  1  3/39 (7.69%)  3 0/42 (0.00%)  0
Hepatic enzyme increased  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Liver function test increased  1  1/39 (2.56%)  1 0/42 (0.00%)  0
N-terminal prohormone brain natriuretic peptide increased  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Weight decreased  1  6/39 (15.38%)  6 0/42 (0.00%)  0
Weight increased  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  3/39 (7.69%)  3 1/42 (2.38%)  1
Dehydration  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Diabetes mellitus inadequate control  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Fluid overload  1  1/39 (2.56%)  1 2/42 (4.76%)  2
Gout  1  3/39 (7.69%)  3 0/42 (0.00%)  0
Hyperkalaemia  1  3/39 (7.69%)  3 5/42 (11.90%)  5
Hyperuricaemia  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Hypomagnesaemia  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Increased appetite  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Magnesium deficiency  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Metabolic acidosis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Type 2 diabetes mellitus  1  4/39 (10.26%)  4 0/42 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Arthritis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Back pain  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Bursitis  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Flank pain  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Muscle spasms  1  9/39 (23.08%)  9 8/42 (19.05%)  8
Muscular weakness  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Myalgia  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Pain in extremity  1  1/39 (2.56%)  2 1/42 (2.38%)  1
Rotator cuff syndrome  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Monoclonal gammopathy  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Dysgeusia  1  2/39 (5.13%)  2 1/42 (2.38%)  1
Headache  1  2/39 (5.13%)  2 4/42 (9.52%)  6
Paraesthesia  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Tremor  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Psychiatric disorders     
Confusional state  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Insomnia  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Dysuria  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Haematuria  1  2/39 (5.13%)  2 0/42 (0.00%)  0
Micturition urgency  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Pollakiuria  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Renal pain  1  0/39 (0.00%)  0 2/42 (4.76%)  2
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Bronchial hyperreactivity  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Cough  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Dyspnoea  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Oropharyngeal pain  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders     
Acne  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Dermal cyst  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Hyperhidrosis  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Ingrowing nail  1  1/39 (2.56%)  2 0/42 (0.00%)  0
Rash macular  1  1/39 (2.56%)  1 1/42 (2.38%)  1
Skin ulcer  1  1/39 (2.56%)  1 0/42 (0.00%)  0
Surgical and medical procedures     
Meniscus operation  1  0/39 (0.00%)  0 1/42 (2.38%)  1
Vascular disorders     
Hypertension  1  0/39 (0.00%)  0 2/42 (4.76%)  2
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right to review all planned communications and manuscripts based on the results of the study, to allow the Sponsor to confirm the accuracy of the data, to protect proprietary information, and to provide comments based on information that may not yet be available to study investigators.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Science Liaison
Organization: Reata Pharmaceuticals, Inc.
Phone: +1 972-865-2219
EMail: MedicalAffairs-Team@reatapharma.com
Layout table for additonal information
Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04702997    
Other Study ID Numbers: 402-C-2002
First Submitted: January 7, 2021
First Posted: January 11, 2021
Results First Submitted: November 4, 2022
Results First Posted: December 1, 2022
Last Update Posted: December 1, 2022