Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03126318
Eligibility Criteria:
Inclusion Criteria:
1. CKD stage III or IV
2. Serum CRP \> 2 mg/L measured twice during the Screening period at least one week apart
3. Urine protein excretion \< 3.5 g/24h estimated by a spot urine protein/creatinine ratio
4. The patient agrees to comply with the contraception and reproduction restrictions of the study - use 2 forms of acceptable contraception
Exclusion Criteria:
1. Patients with advanced CKD requiring chronic dialysis
2. Hospitalization over the period of 6 weeks prior to randomization
3. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs anytime during the study Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary.
4. History of or expected to undergo living related kidney transplant during the study period
5. Currently receiving or planning to receive live or inactivated vaccines
6. Clinical evidence or suspicion of active or smoldering infection (e.g., diabetic foot ulcer) or use of antibiotics during the Screening period
7. History of a positive PPD or prior diagnosis of tuberculosis
8. Evidence of HIV infection or carrier state by serology at Screening
9. Hepatitis B or C by serology (i.e. Hepatitis B Surface Antigen or Hepatitis C antibody positive) at Screening
10. AST or ALT \> 2.5x ULN at Screening
11. History of liver cirrhosis or home oxygen use
12. History of gastrointestinal ulceration or active diverticulitis in the 1 year prior to Screening
13. Absolute neutrophil count \< 2 x 109/L at Screening
14. Platelet count \< 100 x 109/L at Screening
15. Participated in an investigational drug study within 30 days of Screening or Screening is within 5 half-lives of the investigational compound.
16. Known allergy to the study drug or any of its ingredients
17. Breastfeeding or a positive pregnancy test at Screening or Day -1.
18. Any condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would in the opinion of the Investigator increase the risk of the subject's participation in the study.
This would include but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy, anemia attributable to a primary hematologic disease (e.g., sickle cell anemia), or any unexplained blackouts.
19. Actively treated malignancy (other than non-melanoma skin cancers) during the 1 year prior to Screening. Patients receiving hormonal treatment only during this period only may be enrolled with the approval of the medical monitor.
20. Myocardial infarction during the 3 months prior to Screening or during Screening
21. Severe arthritis, lupus, inflammatory bowel disease, asthma or other disease(s) or medical condition(s) that, in the opinion of the investigator, could interfere with hs-CRP or immune function
22. Use of CYP substrates with a narrow therapeutic index (please see detailed table below).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03126318
Study Brief:
Protocol Section:
NCT03126318