Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Chronic Kidney Disease
• Age: Between 18 Year(s) - 100 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Primary IgAN, as evidenced by a kidney biopsy performed within 7 years prior to or during screening, without known secondary cause
  2. Treatment with maximum tolerated doses of ACE inhibitors or ARBs for at least 90 days immediately prior to screening, except for interruptions due to illness (not greater than 7 consecutive days)
  3. Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment
     • Vaccination must include coverage of serogroups A, C, W, and Y. Vaccination against serogroup B should be administered according to local guidelines and national availability
     • If vaccination is required during screening, completion of vaccination must take place at least 2 weeks prior to the first dose of RO7434656.
  4. Vaccination against Streptococcus pneumoniae
     • If vaccination is required during screening, completion of vaccination must take place at least 2 weeks prior to the first dose of RO7434656.
  5. Vaccination against Haemophilus influenzae according to national vaccination recommendations for patients receiving complement inhibitors
     • If vaccination is required during screening, completion of vaccination must take place at least 2 weeks prior to the first dose of RO7434656.
  6. Negative for HIV, hepatitis B, and hepatitis C
  7. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 12 weeks after the final dose of RO7434656
     • A female participant is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (? 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with a tubal ligation is considered to be of childbearing potential.
     • The following are examples of adequate contraceptive methods: bilateral tubal ligation; male sterilization; hormonal contraceptives; hormone-releasing intrauterine devices; copper intrauterine devices; male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide. A male condom and a female condom should not be used together because of risk of failure due to friction.
     • For participants receiving concurrent medication known to reduce the effectiveness of hormonal contraceptives, use of the copper intrauterine device, hormone-releasing intrauterine system, or depot medroxyprogesterone acetate is recommended instead of using combined hormonal contraception, progestogen-only pills, or the etonogestrel implant.
  8. For male participants: no contraception requirements

  
  

You may not be eligible for this study if the following are true:

• 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of RO7434656
  2. Histopathologic or other evidence of another autoimmune glomerular disease
  3. Uncontrolled blood pressure for 3 months prior to screening or during screening
  4. Initiation of SGLT2 inhibitors within 16 weeks prior to screening or during screening
     • Doses of these agents must be stable for 90 days prior to screening without intent to increase further. Formulations of these agents in combination with anti-diabetic agents are prohibited.
  5. Use of endothelin receptor antagonists, except those approved for use in IgAN
  6. Initiation of mineralocorticoid receptor antagonists or endothelin receptor antagonists within 90 days prior to screening or during screening
  7. Initiation of non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening:
     • Doses of these agents must be stable for 90 days prior to screening without intent to increase further.
  8. Use of herbal therapies within 90 days prior to or during screening
  9. Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening, whichever is longer
  10. Treatment with an investigational therapy planned during the treatment period
  11. Previous treatment with RO7434656
  12. Treatment with oral or IV corticosteroids with a dose equivalent to = 7.5 mg/day of prednisone for 7 days or equivalent to = 5 mg/day of prednisone for 14 days within 90 days prior to screening
  13. Patients must not receive oral or IV corticosteroids during screening.
  14. Treatment with a calcineurin inhibitor within 2 months prior to screening or during screening
  15. Treatment with anti-CD20 therapy within 9 months of screening or during screening
  16. Treatment with other immunomodulatory agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), or mycophenolate
  17. Planned major procedure or major surgery during screening or the study
  18. Substance abuse within 12 months prior to screening or during screening
  19. Known history of HIV
  20. Tuberculosis (TB) infection
      • Testing for latent TB infection will be performed at screening if required by local regulations or in accordance with local
      • Latent TB infection under treatment initiated at least 2 weeks prior to randomization as guided by local regulations or in accordance with local clinical practice is not exclusionary.
  21. Serious infection requiring hospitalization or IV antibiotics (or anti-infective agents) within 8 weeks prior to screening or during screening
  22. Serious infection requiring treatment with oral antibiotics (or anti-infective agents) within 14 days prior to screening or during screening
  23. Splenectomy < 24 months prior to screening or during screening
  24. Receipt of a live, attenuated vaccine within 30 days before randomization
  25. History of malignancy within <5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate > 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
  26. History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
  27. Current treatment with medications that are well known to prolong the QT interval