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Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

ConditionC3G
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-60
SponsorNovartis Pharmaceuticals

About this trial

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.

The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female participants age ≥ 12 and ≤ 60 years at screening.

Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.

Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.

Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.

Disqualifiers

Participants who have received any cell or organ transplantation, including a kidney transplantation.

Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.

Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%

Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

  • iptacopan

    Drug

    iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: iptacopan 200mgExperimental treatment 1 intervention
Group B: Placebo to iptacopan 200mgPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)

To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months of treatment.

Time frame
6 months (double-blind)
2

Adolescent cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection)

To evaluate the effect of iptacopan on proteinuria at 6 months.

Time frame
6 months (double-blind)
3

Change from baseline in log-transformed UPCR at the 12-month visit (both study treatment arms).

To evaluate the effect of iptacopan on proteinuria at 12 months.

Time frame
12 months (double-blind and open-label)
4

Change in log-transformed UPCR from the 6-month visit to the 12-month visit in the placebo arm

To evaluate the effect of iptacopan on proteinuria at 12 months.

Time frame
From month 6 to month 12 (open-label)

Secondary outcomes

1

Change from baseline in eGFR.

To demonstrate the superiority of iptacopan vs. placebo in improving eGFR.

Time frame
6 months (double-blind)
2

Proportion of participants who meet the criteria for achieving a composite renal endpoint

To demonstrate the superiority of iptacopan vs. placebo in the proportion of participants who meet the criteria for achieving a composite renal endpoint. A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the baseline visit.

Time frame
6 months (double-blind)
3

Adult cohort: Change from baseline in disease total activity score in a renal biopsy.

To demonstrate the effect of iptacopan vs placebo in reducing glomerular inflammation in the kidney.

Time frame
6 months (double-blind)
4

Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score.

To assess the effect of iptacopan compared to placebo in improvement of patient reported fatigue.

Time frame
6 months (double-blind)

Other outcomes

Sponsors and contacts

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Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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