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

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ClinicalTrials.gov Identifier: NCT03710291
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Tricida, Inc.

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 average duration of follow-up is anticipated to be 3.5 years.

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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 : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: TRC101 Drug: TRC101
Oral, non-absorbed, polymeric hydrochloric acid binder
Other Name: Veverimer

Placebo Comparator: Placebo Drug: Placebo
Placebo comparator




Primary Outcome Measures :
  1. Progression of chronic kidney disease. [ Time Frame: Through study completion, on average 3.5 years. ]
    Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.


Secondary Outcome Measures :
  1. Time to ESRD. [ Time Frame: Through study completion, on average 3.5 years. ]
    Time to either chronic dialysis or kidney transplant.

  2. eGFR slope. [ Time Frame: Through study completion, on average 3.5 years. ]
    Change in eGFR over time.

  3. KDQOL. [ Time Frame: Through study completion, on average 3.5 years. ]
    Kidney Disease Quality of Life Physical Functioning Survey.

  4. CKD progression or cardiovascular death [ Time Frame: Through study completion, on average 3.5 years. ]
    Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; or cardiovascular death.

  5. All-cause hospitalization. [ Time Frame: Through study completion, on average 3.5 years. ]
    Hospitalization or >24 hours emergency department stay.



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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.

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


Contacts
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Contact: Yuri Stasiv, PhD 415-988-5120 ystasiv@tricida.com

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Sponsors and Collaborators
Tricida, Inc.

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Responsible Party: Tricida, Inc.
ClinicalTrials.gov Identifier: NCT03710291     History of Changes
Other Study ID Numbers: TRCA-303
2018-001303-36 ( EudraCT Number )
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
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
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases