Glomerulonephritis Clinical Trials

• The patient is willing and able to provide signed informed consent.

• The patient can understand written and spoken English.

• The patient is male or female, aged ≥18 years.

• The patient has been diagnosed with biopsy-proven IgAN within the last 6 months (calculated from the date of kidney biopsy, upon which the IgAN-positive diagnosis was made, to the signing of the informed consent form).

• The patient has a urine total protein value ≥0.5 g/day at screening.

• The patient has an eGFR value ≥30 mL/min/1.73 m2 at screening.

• The patient has not previously been treated with ACEI and/or ARB therapy for IgAN OR has not received ACEI and/or ARB therapy within the last 12 months.

• The patient has a systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.

• Women of childbearing potential (WOCBP), beginning at menarche, must agree to the use of one highly reliable (ie, can achieve a failure rate of \<1% per year) method of contraception from 7 days prior to the first dose of trial medication until 90 days after the last dose of trial medication. Highly reliable contraception methods include stable oral, implanted, transdermal, or injected contraceptive hormones associated with inhibition of ovulation, or an intrauterine device (IUD) in place for at least 3 months. One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide), from Day 1 until 90 days after the last dose of trial medication.

⁃ WOCBP are defined as those who are fertile, following menarche and until becoming postmenopausal unless permanently sterile; permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as amenorrhoea for more than 24 consecutive months without an alternative medical cause; women on hormone replacement therapy must have a documented plasma follicle-stimulating hormone level ≥40 mIU/mL. All WOCBP must have a negative pregnancy test at Visit 1 (serum test) and Visit 2 (urine, with positive results confirmed by serum).

• Male and female aged ≥18 years

• Diagnosis of recurrent IgAN based on histological analysis of a transplanted kidney biopsied within the last 6 months

• A time period of \>12 months since kidney transplantation

• UPCR ≥50 mg/mmol (≥0.44 g/g) and eGFR value ≥25 mL/min/1.73 m2

• For patients on an ACEI and/or ARB, and/or SGLT2 inhibitor, the dosing regimen is stable for at least 6 weeks prior to and during the screening period

• Tacrolimus treatment as part of standard of care immunosuppression following kidney transplantation

• Systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.

• Female patients not of childbearing potential, or of childbearing potential and agreeing to use the contraceptive methods listed in Section 5.1