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Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis (VALOR-CKD)

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: NCT03710291
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Tricida, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

Condition or disease Intervention/treatment Phase
Metabolic Acidosis Chronic Kidney Disease Drug: TRC101 Drug: Placebo Phase 3

Detailed Description:
This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: TRC101 Drug: TRC101
Oral, non-absorbed, polymeric hydrochloric acid binder
Other Name: Veverimer
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. Progression of chronic kidney disease [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.


Secondary Outcome Measures :
  1. Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to first occurrence of: death (all-cause); ESRD; a confirmed ≥50% reduction in eGFR.

  2. Physical functioning (subjective) [ Time Frame: 18 months after randomization. ]
    Kidney Disease Quality of Life Physical Functioning Survey.

  3. Physical functioning (objective) [ Time Frame: 18 months after randomization. ]
    Repeated chair stand test.

  4. ESRD or renal death [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to ESRD or renal death.

  5. Primary outcome measure OR cardiovascular death [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death.

  6. Serum creatinine [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to first occurrence of a confirmed doubling of serum creatinine.

  7. ≥50% reduction in eGFR [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to first occurrence of a confirmed ≥50% reduction in eGFR.

  8. ≥40% reduction in eGFR [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to first occurrence of a confirmed ≥40% reduction in eGFR.

  9. All-cause hospitalization [ Time Frame: Through study completion, up to approximately 6 years. ]
    Frequency of all-cause hospitalization.

  10. Cardiovascular death [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to cardiovascular death.

  11. All-cause mortality [ Time Frame: Through study completion, up to approximately 6 years. ]
    Time to all-cause mortality.


Other Outcome Measures:
  1. Safety of TRC101 [ Time Frame: Through study completion, up to approximately 6 years. ]
    Frequency, intensity, and relationship to study drug of adverse events and serious adverse events.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^2.
  • Serum bicarbonate 12 - 20 mEq/L.
  • On maximum tolerated dose of ACE inhibitor and/or ARB.

Exclusion Criteria:

  • Acute metabolic acidosis.
  • Anticipated dialysis or kidney transplant within 6 months.
  • Recent acute kidney injury.
Contacts and Locations
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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): NCT03710291


Locations
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Sponsors and Collaborators
Tricida, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tricida, Inc.
ClinicalTrials.gov Identifier: NCT03710291    
Other Study ID Numbers: TRCA-303
2018-001303-36 ( EudraCT Number )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
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.:
serum bicarbonate
renal outcomes
TRC101
eGFR
veverimer
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
 Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases