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Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

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: NCT02809183
Recruitment Status : Completed
First Posted : June 22, 2016
Results First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Tricida, Inc.

Brief Summary:

This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study was conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) continued for 14 days twice daily (BID). In Part 2 study drug dosing (TRC101 or placebo) continued for 14 days once daily (QD).

The maximum study duration per subject was anticipated to be up to 42 days.


Condition or disease Intervention/treatment Phase
Acidosis Drug: Placebo Drug: TRC101 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of TRC101 in Subjects With Chronic Kidney Disease and Low Serum Bicarbonate Levels
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Placebo Comparator: Placebo-BID
Administered twice daily (BID) for 14 days
Drug: Placebo
oral suspension

Experimental: TRC101 (1.5g BID)
Administered twice daily (BID) for 14 days
Drug: TRC101
oral suspension
Other Name: Veverimer

Experimental: TRC101 (3g BID)
Administered twice daily (BID) for 14 days
Drug: TRC101
oral suspension
Other Name: Veverimer

Experimental: TRC101 (4.5g BID)
Administered twice daily (BID) for 14 days
Drug: TRC101
oral suspension
Other Name: Veverimer

Experimental: TRC101 (6g QD)
Administered once daily (QD) for 14 days
Drug: TRC101
oral suspension
Other Name: Veverimer

Placebo Comparator: Placebo-QD
Administered once daily (QD) for 14 days
Drug: Placebo
oral suspension




Primary Outcome Measures :
  1. Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE [ Time Frame: Through treatment period completion (Day 15) ]
    The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive.

  2. Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group [ Time Frame: Baseline and Day 15 ]
    Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline


Secondary Outcome Measures :
  1. Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo [ Time Frame: Baseline and Day 15 ]
    Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for each TRC101 dose group versus that for Placebo

  2. Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group [ Time Frame: Baseline and Day 15 ]
    Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

  3. Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo [ Time Frame: Baseline and Day 15 ]
    Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the Combined TRC101 Treatment Group versus that for Placebo

  4. Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo [ Time Frame: Baseline and Day 15 ]
    Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between each TRC101 BID Dose Group versus Placebo

  5. Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group [ Time Frame: Baseline and Day 15 ]
    Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

  6. Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo [ Time Frame: Baseline and Day 15 ]
    Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g dose group versus that for Placebo

  7. Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group [ Time Frame: Baseline and Day 15 ]
    Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g QD dose group versus that for the TRC101 3g BID dose group

  8. Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo [ Time Frame: Baseline and Day 15 ]
    Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between the 6g TRC101 QD Dose Group versus Placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) of 20 to <60 mL/min/1.73m2
  • Serum bicarbonate level of 12 to 20 mEq/L

Exclusion Criteria:

  • Any level of low serum bicarbonate that, in the opinion of the Investigator, requires emergency intervention.
  • Severe comorbid conditions other than chronic kidney disease.
  • Chronic obstructive pulmonary disease.
  • Anticipated changes in doses of any of the following drugs or drug classes: diuretics, non-ophthalmic carbonic anhydrase inhibitors, oral diabetes drugs, antihypertensive drugs, antacids, H2-blockers, or proton pump inhibitors.
  • Excluded drugs or drug classes: insulin, non-daily or "as needed" diuretics, herbal products, dietary supplements, multivitamins, naturopathic remedies, sodium bicarbonate, potassium citrate, sodium citrate or other alkali therapy, non-steroidal anti-inflammatory drugs (NSAIDs), fiber supplements, laxatives, calcium and magnesium supplements, or electrolyte binders and other binder drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809183


Locations
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Bulgaria
Investigative Site 1
Sofia, Bulgaria
Georgia
Investigative Site 3
Tbilisi, Georgia
Investigative Site 4
Tbilisi, Georgia
Investigative Site 5
Tbilisi, Georgia
Investigative Site 6
Tbilisi, Georgia
Sponsors and Collaborators
Tricida, Inc.
Investigators
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Study Director: Yuri Stasiv, PhD Tricida, Inc.
Publications of Results:
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Responsible Party: Tricida, Inc.
ClinicalTrials.gov Identifier: NCT02809183    
Other Study ID Numbers: TRCA-101
2015-004327-31 ( EudraCT Number )
First Posted: June 22, 2016    Key Record Dates
Results First Posted: January 14, 2020
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tricida, Inc.:
metabolic acidosis
serum bicarbonate
kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases