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

T

Tricida

Status and phase

Completed
Phase 2
Phase 1

Conditions

Acidosis

Treatments

Drug: Placebo
Drug: TRC101

Study type

Interventional

Funder types

Industry

Identifiers

NCT02809183
2015-004327-31 (EudraCT Number)
TRCA-101

Details and patient eligibility

About

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.

Enrollment

135 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

135 participants in 6 patient groups, including a placebo group

Placebo-BID
Placebo Comparator group
Description:
Administered twice daily (BID) for 14 days
Treatment:
Drug: Placebo
TRC101 (1.5g BID)
Experimental group
Description:
Administered twice daily (BID) for 14 days
Treatment:
Drug: TRC101
TRC101 (3g BID)
Experimental group
Description:
Administered twice daily (BID) for 14 days
Treatment:
Drug: TRC101
TRC101 (4.5g BID)
Experimental group
Description:
Administered twice daily (BID) for 14 days
Treatment:
Drug: TRC101
TRC101 (6g QD)
Experimental group
Description:
Administered once daily (QD) for 14 days
Treatment:
Drug: TRC101
Placebo-QD
Placebo Comparator group
Description:
Administered once daily (QD) for 14 days
Treatment:
Drug: Placebo

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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