Chronic kidney disease MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Tricida Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects 18 to 85 years of age, inclusive. 2. The mean of two Screening eGFR measurements, drawn at least 2 weeks apart and both within 6 weeks of the first day of Part A, is 20 to 40 mL/min/1.73m2, inclusive. 3. Have stable renal function as defined by eGFR Screening values that are not different by > 20% (the higher of the two Screening eGFR values will be used as the denominator to calculate the 20% allowable difference) 4. Based on onsite measurement using an iSTAT point of care device, have three serum bicarbonate values, each = 2 weeks apart from each other and all within 6 weeks of the A1 Visit, in the range from 12 to 20 mEq/L, inclusive. 5. Mean systolic and diastolic blood pressure (determined as the average of three replicates) must be =65 years) yes F.1.3.1 Number of subjects for this age range 1500
Exclusion criteria
Exclusion criteria: 1. Have any level of low serum bicarbonate at either Screening Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process. 2. Have had anuria, dialysis, or acute kidney injury/acute renal failure in the 3 months prior to the Screening 1 Visit. 3. Had heart failure with maximum New York Heart Association (NYHA) Class IV symptoms during the 3 months prior to the Screening 1 Visit. 4. Had a heart, liver or kidney transplant. 5. Have a corrected serum calcium < 8.0 mg/dL (80 mg/L; 2 mmol/L) at the Screening 1 Visit, based on central laboratory measurement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of TRC101 on the progression of chronic kidney disease and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.;Secondary Objective: Not applicable.;Primary end point(s): Progression of chronic kidney disease, defined by time to first occurrence of any event in the composite endpoint consisting of the following as adjudicated by the independent blinded Clinical Endpoint Adjudication Committee (CEAC): • A confirmed = 40% reduction in eGFR • End-stage renal disease (ESRD) • Renal death;Timepoint(s) of evaluation of this end point: The time to first occurrence of any component of the composite endpoint as adjudicated by an independent blinded CEAC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to first occurrence of any event in the composite of death (all cause), ESRD, or a confirmed = 50% reduction in eGFR 2. Change from baseline (i.e., A1 Visit) to Month 12 in the total score of the KDQOL-PFD 3. Change from baseline (i.e., A1 Visit) to Month 12 in the time to complete the repeated chair stand test 4. Time to ESRD or renal death 5. Time to first occurrence of the primary composite endpoint or cardiovascular (CV) death 6. Time to first occurrence of a confirmed doubling of serum creatinine 7. Time to first occurrence of a confirmed = 50% reduction in eGFR 8. Time to first occurrence of a confirmed = 40% reduction in eGFR 9. Frequency of all-cause hospitalization 10. Time to CV death 11. Time to all-cause mortality With the exception of endpoints #2, #3, #6 and #9, all secondary endpoint events will be adjudicated by the CEAC. ;Timepoint(s) of evaluation of this end point: 1. Time to first occurrence of any event in the composite of death (all cause), ESRD or a confirmed = 50% reduction in eGFR 2. At Month 12 3. At Month 12 4. Time to occurrence of ESRD or renal death 5. Time to first occurrence of primary composite endpoint or CV death 6. Time to first occurrence of a confirmed doubling of serum creatinine 7. Time to first occurrence of a confirmed = 50% reduction in eGFR 8. Time to first occurrence of a confirmed = 40% reduction in eGFR 9. At the end of treatment 10. Time to CV death 11. Time to all-cause mortality | — |
Countries
Albania, Argentina, Armenia, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Czech Republic, France, Georgia, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, North Macedonia, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Operations
Tricida, Inc.
Outcome results
None listed