A clinical study with patients who have increased acid in their blood because of chronic kidney disease that is testing if the experimental drug TRC101, compared to placebo (a substance that does not contain medicine), is safe and if it slows down worsening of kidney disease.
- Conditions
- Chronic kidney diseaseMedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2018-001303-36-BE
- Lead Sponsor
- Tricida Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 3000
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 < 160/92 mmHg at the Screening 2 Visit.
6. Receiving treatment with an ACE inhibitor and/or ARB at the maximum tolerated (for the individual subject) dose within the country-specific labeled dose range, without adjustments, for = 4 weeks prior to the Screening 1 Visit and during the Screening Period.
7. If receiving an oral alkali supplement, the dose must be stable for = 2 weeks prior to Screening 1 Visit and during the Screening Period. If not receiving alkali treatment, there must be no such treatment within the 2 weeks prior to Screening 1 Visit or during the Screening Period.
8. Have a hemoglobin A1c (HbA1c) value of = 11.0% (0.11 fraction; 97 mmol/mol) at the Screening 1 Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1500
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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):<br>• A confirmed = 40% reduction in eGFR<br>• End-stage renal disease (ESRD)<br>• 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 Outcome Measures
Name Time Method