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A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)

ConditionFocal Segmental Glomerulosclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkebia Therapeutics

About this trial

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). Participants will be randomized 1:1 to receive praliciguat or placebo for initial 24 week treatment period. Following this double-blind period, all participants will receive praliciguat in an open-label period for an additional 24 weeks. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

UPCR ≥1 (g/g) during screening.

On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.

Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS.

Disqualifiers

Collapsing FSGS in the kidney biopsy report.

Sickle cell disease.

HbA1c >8%.

Uncontrolled hypertension (≥160/100 millimeters of mercury).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Praliciguat (Part A)

    Drug

    Oral Tablet

  • Placebo (Part A)

    Other intervention

    Oral Tablet

  • Praliciguat (Part B)

    Drug

    Oral Tablet

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Praliciguat (Part A)Experimental treatment 1 intervention
Group B: Placebo (Part A)Placebo comparator 1 intervention
Group C: Experimental: Long-term safety extension praliciguat (Part B)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in urine protein-to-creatinine ratio (UPCR) (Part A)

Time frame
Baseline (Day 1) and up to Week 24
2

Proportion of participants with TEAEs, serious adverse events (SAEs), and treatment-emergent adverse events of special interest (AESIs). (Part A)

Time frame
Time Frame: Up to Week 52

Secondary outcomes

1

Percentage of Participants with Partial Remission at Week 24 (Part A)

Partial remission is defined as 40% UPCR reduction and UPCR\<1.5 gram/gram (g/g).

Time frame
Up to Week 24
2

Plasma concentrations of praliciguat (Part A)

Time frame
Week 24, Week 32, and Week 36
3

Incidence of TEAEs, SAEs, and AESIs in the long-term safety extension (Part B)

Time frame
From Week 48 Part A through study completion

Other outcomes

Sponsors and contacts

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Akebia Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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