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

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

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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