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

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ClinicalTrials.gov Identifier: NCT02809183
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Tricida, Inc.

Brief Summary:

This is a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study will enroll approximately 130 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels. The study will be conducted in two parts. In Part 1 study drug dosing (TRC101 or placebo) will continue for 14 days twice daily. In Part 2 study drug dosing (TRC101 or placebo) will continue for 14 days once daily.

The maximum study duration is anticipated to be up to 42 days.


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

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
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
Other Name: microcrystalline cellulose

Experimental: TRC101 (Dose 1-BID)
Administered twice daily (BID) for 14 days
Drug: TRC101
oral suspension

Experimental: TRC101 (Dose 2-BID)
Administered twice daily (BID) for 14 days
Drug: TRC101
oral suspension

Experimental: TRC101 (Dose 3-BID)
Administered twice daily (BID) for 14 days
Drug: TRC101
oral suspension

Experimental: TRC101 (Dose 2-QD)
Administered once daily (QD) for 14 days
Drug: TRC101
oral suspension

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




Primary Outcome Measures :
  1. The primary objective of this first-in-human study is to evaluate the safety and tolerability of TRC101. The primary outcome measure is the comparison across dose groups of the cumulative percentage of treatment-emergent adverse events. [ Time Frame: Through study completion, up to 4 weeks. ]
    The number and percentage of subjects who reported treatment-emergent adverse events will be summarized by system organ class and preferred term; as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses will be descriptive.


Secondary Outcome Measures :
  1. The secondary outcome measure is the change from baseline in serum bicarbonate to the end of 2-week treatment period within individual TRC101 dose group. [ Time Frame: Through treatment period completion, up to 2 weeks. ]
    Efficacy data will be summarized by dose group based on the randomized treatment group assignment. Descriptive statistics of efficacy data will be provided for all scheduled time points.



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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
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
Study Director: Yuri Stasiv, PhD Tricida, Inc.

Responsible Party: Tricida, Inc.
ClinicalTrials.gov Identifier: NCT02809183     History of Changes
Other Study ID Numbers: TRCA-101
2015-004327-31 ( EudraCT Number )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tricida, Inc.:
metabolic acidosis
serum bicarbonate
kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases