Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kyowa Kirin, Inc.
With
Kyowa Kirin Co., Ltd.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Have participated in Kyowa Hakko Kirin Pharma, Inc.'s KRN23-INT-001 (NCT01340482) or KRN23-INT-002 (NCT01571596) studies (received at least 2 doses of KRN23)
2. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min or eGFR of 45 to \< 60 mL/min at Screening with confirmation that the renal insufficiency was not due to nephrocalcinosis.
3. Sexually active subjects must be willing to use an acceptable method of contraception (e.g., double barrier method) while participating in the study and for 30 days after receiving the last dose of KRN23.
You may not be if
1. Subject experienced a safety-related event in the KRN23-INT-001 or KRN23-INT-002 study that, in the opinion of the investigator and sponsor, precludes resuming KRN23 treatment.
2. Presence of nephrocalcinosis on renal ultrasound that, in the opinion of the investigator and sponsor, precludes resuming KRN23 treatment.
3. Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
4. Participation in an investigational drug or device trial within 30 days of enrollment (other than KRN23-INT-001 or KRN23-INT-002).
5. Use of a pharmacologic vitamin D metabolite or analog (e.g., calcitriol, doxercalciferol, and paricalcitol), phosphate, or aluminum hydroxide antacids (e.g., Maalox® and Mylanta®) within 21 days prior to Screening or during the study.
6. Use of medication to suppress parathyroid hormone (PTH) (e.g., Sensipar®, cinacalcet, calcimimetics) within 2 months prior to Screening.
