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Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

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

About this trial

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).

Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).

Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization

UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15

Disqualifiers

Participants who have undergone cell or solid organ transplantation, including kidney transplantation.

Deposition of antigen-antibody immune complexes as a result of any chronic infections, including

Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);

Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections

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

106 Participants
are divided into 2 treatment groups
Group A: iptacopan 200mg b.i.dExperimental treatment 1 intervention
Group B: Placebo to iptacopan 200mg b.i.d.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.

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

Time frame
6 months (double-blind)
2

Log-transformed ratio to baseline in UPCR at the 18-month visit (each study treatment arm)

To evaluate the effect of iptacopan on proteinuria at 18 months.

Time frame
18 months
3

Log-transformed ratio to 12-month visit in UPCR at the 18-month visit in the placebo arm.

To evaluate the effect of iptacopan on proteinuria at 18 months.

Time frame
18 months

Secondary outcomes

1

Change from baseline in eGFR

To demonstrate the superiority of iptacopan vs. placebo in improving estimated glomerular filtration rate (eGFR).

Time frame
12 months and 18 months
2

Change in eGFR from the 12-month visit to the 18- month visit of the placebo arm

To evaluate the effect at 18 months of iptacopan in improving eGFR

Time frame
18 months
3

Proportion of patients achieved a composite renal endpoint

To demonstrate the superiority of iptacopan vs. placebo in the proportion of participant who achieved a composite renal endpoint at 6 and 12 months (each study arm).

Time frame
6 and 12 months
4

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

To demonstrate the superiority of iptacopan compared to placebo in improvement of patient-reported fatigue at 12 months (each study arm).

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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