ClinicalTrials.Veeva

Menu

A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis

Reata Pharmaceuticals logo

Reata Pharmaceuticals

Status and phase

Withdrawn
Phase 2

Conditions

End-Stage Renal Disease
Type 2 Diabetes Mellitus

Treatments

Drug: Bardoxolone Methyl 20 mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01576887
2012-001563-78 (EudraCT Number)
402-C-1201

Details and patient eligibility

About

This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.

Full description

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients must have ESRD and been on PD for longer than 3 months
  2. Patients must have had a diagnosis of T2DM prior to starting dialysis
  3. Patients must have RRF, as defined by the mean of urea and creatinine clearance on a 24 hour urine collection, ≥ 25 Liters/week/1.73 m2 documented in the four months prior to the Screen A visit
  4. Patients must have RRF, as defined by the mean of urea and creatinine clearances on a 24 hour urine collection, ≥ 25 Liters/week/1.73 m2 at both the Screen A and Screen B visits
  5. The RRF value obtained at the Screen B visit, must not be less than 50% of the RRF value obtained at the Screen A visit
  6. Patients must be at least 18 years of age
  7. Patients must have a mean systolic blood pressure (SBP) on three readings at both Screen A and Screen B visits ≤ 160 mmHg and ≥ 90 mmHg
  8. Patients must have a mean diastolic blood pressure (DBP) on three readings at both Screen A and Screen B visits < 100 mmHg and ≥ 40 mmHg
  9. Patients must be willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during screening, while taking study drug and for at least 30 days after the last dose of study drug is ingested
  10. Patients must be willing and able to cooperate with all aspects of the protocol
  11. Patients must be willing and able to give written informed consent to participate in the study. They must provide consent for access to medical data according to appropriate local data protection legislation and allow authorization to access medical records that describe events captured in the endpoints

Exclusion criteria

  1. History of Autosomal Dominant Polycystic Kidney Disease

  2. Currently Active Systemic Lupus Erythematosus

  3. History of Hepatitis B Surface Antigen +

  4. History of Hepatitis C Antibody + being treated with antiviral therapy

  5. History of an organ transplant

  6. A planned renal transplant from a living donor during the study

  7. History of hospitalization for congestive heart failure or pulmonary edema within 12 weeks before study randomization

  8. History of cirrhosis of the liver

  9. History of amyloidosis or light chain nephropathy

  10. History of hemoglobin A1c level > 11.0% (97 mmol/mol) within 12 weeks before study randomization

  11. History of recently active cardiovascular disease defined as:

    1. Unstable angina pectoris within 12 weeks before study randomization
    2. Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 12 weeks before study randomization
    3. Cerebrovascular accident, including transient ischemic attack within 12 weeks before study randomization
  12. History of a diagnostic or interventional procedure that required intravenous administration of an iodinated contrast agent or gadolinium within 12 weeks before study randomization

  13. History of known severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy

  14. History of known 2o or 3o atrioventricular block not successfully treated with a pacemaker

  15. History or resuscitated sudden cardiac death

  16. History of an automatic implantable defibrillator

  17. QTc greater than 0.50 seconds on an ECG obtained during either Screen A or Screen B visits

  18. A serum magnesium level less than 1.4 meq/L on either Screen A or Screen B visit laboratory test results

  19. History of systemic immunosuppression for more than 15 days, cumulatively, within the 12 weeks prior to study randomization or anticipated need for more than 15 days of immunosuppression during the study

  20. Total bilirubin, aspartate transaminase (AST), or alanine transaminase (ALT) level greater than the upper limit of normal (ULN) or alkaline phosphatase level greater than two times the ULN on either the Screen A and Screen B visit laboratory test results

  21. Known hypersensitivity to any component of the study drug

  22. Current history of drug or alcohol abuse, as assessed by the investigator

  23. History of clinically significant infection requiring intravenous administration of antibiotics or hospitalization within 12 weeks before study randomization

  24. In patients who have been on peritoneal dialysis for ≥ 6 months, two or more episodes of peritonitis in the 6 months before study randomization. In patients who have been on peritoneal dialysis for <6 months, one episode of peritonitis before study randomization

  25. History of a diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix

  26. History of a clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the patient while involved in the study

  27. Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function

  28. Participation in a clinical study involving any intervention within 30 days prior to Screen A visit, concurrent participation in such a study, or participation in a prior clinical study involving bardoxolone methyl in any form

  29. Female patients who are pregnant, intend to become pregnant during this study, or are nursing

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Bardoxolone Methyl
Experimental group
Treatment:
Drug: Bardoxolone Methyl 20 mg

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems