Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

Inclusion Criteria:

- Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before
first dose

- May be the first kidney transplant or a repeat kidney transplant.

- Subjects with a functional, stable kidney transplant, defined as MDRD estimated
glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² (chromic kidney disease stage 3
or better) at Screening.

- Men or women ≥ 18 years at the start of Screening (ie, time of informed consent).

- Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2
values in Screening period.

- iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen
1 or Screen 2).

Exclusion Criteria:

- Received cinacalcet therapy post-transplant for more than 14 days cumulatively
post-transplant. If cinacalcet therapy was received for a total of 14 days or less
post-transplant, there must be a 4-week washout before subject is eligible for
screening (Note: This does not exclude pre-transplant use of cinacalcet).

- Anticipated parathyroidectomy within 6 to12 months after Randomization.

- Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.

- Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites
or analogues) or use within 30 days prior to Screening.

- Ongoing use of calcium supplements or use within 30 days prior to Screening.

- Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30
days prior to Screening.

- Ongoing use of a thiazide diuretic.

- Subjects with a history of seizures who had a seizure within the 3 months prior to
Randomization, which required adjustments to the seizure medication.

- Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it
is an institutional protocol-driven biopsy.