NCT02809183

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

January 14, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

June 14, 2016

Results QC Date

November 21, 2019

Last Update Submit

January 2, 2020

Conditions

Acidosis

Keywords

metabolic acidosisserum bicarbonatekidney disease

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE

    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.

    Through treatment period completion (Day 15)

  • Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group

    Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline

    Baseline and Day 15

Secondary Outcomes (8)

  • Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo

    Baseline and Day 15

  • Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group

    Baseline and Day 15

  • Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo

    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 Dose Group Versus Placebo

    Baseline and Day 15

  • Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group

    Baseline and Day 15

  • +3 more secondary outcomes

Study Arms (6)

Placebo-BID

PLACEBO COMPARATOR

Administered twice daily (BID) for 14 days

Drug: Placebo

TRC101 (1.5g BID)

EXPERIMENTAL

Administered twice daily (BID) for 14 days

Drug: TRC101

TRC101 (3g BID)

EXPERIMENTAL

Administered twice daily (BID) for 14 days

Drug: TRC101

TRC101 (4.5g BID)

EXPERIMENTAL

Administered twice daily (BID) for 14 days

Drug: TRC101

TRC101 (6g QD)

EXPERIMENTAL

Administered once daily (QD) for 14 days

Drug: TRC101

Placebo-QD

PLACEBO COMPARATOR

Administered once daily (QD) for 14 days

Drug: Placebo

Interventions

PlaceboDRUG

oral suspension

Placebo-BIDPlacebo-QD
TRC101DRUG

oral suspension

Also known as: Veverimer
TRC101 (1.5g BID)TRC101 (3g BID)TRC101 (4.5g BID)TRC101 (6g QD)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Investigative Site 1

Sofia, Bulgaria

Location

Investigative Site 3

Tbilisi, Georgia

Location

Investigative Site 4

Tbilisi, Georgia

Location

Investigative Site 5

Tbilisi, Georgia

Location

Investigative Site 6

Tbilisi, Georgia

Location

Related Publications (1)

  • Bushinsky DA, Hostetter T, Klaerner G, Stasiv Y, Lockey C, McNulty S, Lee A, Parsell D, Mathur V, Li E, Buysse J, Alpern R. Randomized, Controlled Trial of TRC101 to Increase Serum Bicarbonate in Patients with CKD. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):26-35. doi: 10.2215/CJN.07300717. Epub 2017 Nov 4.

    PMID: 29102959RESULT

MeSH Terms

Conditions

AcidosisKidney Diseases

Interventions

veverimer

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Medical Information
Organization
Tricida, Inc.
medinfo@tricida.com
415-429-7800

Study Officials

  • Yuri Stasiv, PhD

    Tricida, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 22, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 14, 2020

Results First Posted

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)GE(4)