The primary efficacy endpoint will be correction of vitamin D insufficiency and control of SHPT.
Patients will then be treated with Rayaldee for another 26 weeks in an open-label extension.
Tertiary hyperparathyroidism is a state of excessive secretion of PTH after a long period of SHPT.
It leads to autonomous parathyroid glands that induce hypercalcemia .
Low levels of active vitamin D3 result in a marked decrease in the absorption of dietary calcium, resulting in intermittent hypocalcaemia and sHPT.
Prevention of sHPT should start early, when the eGFR is [less than or equal to] 60 mL/min.
There were no false-positive findings in patients with sHPT.
Results are depicted in Table 2.
We also had shown that cholecalciferol, in combination with paricalcitol, additively lowers the iPTH levels in a significant number of HD patients with SHPT.
A dose of 5000 IU/week of cholecalciferol could maintain serum 25(OH)[D.sub.3] levels above 30 ng/dL as early as 8 weeks after beginning supplementation .
Specifically, per-patient treatment costs covered by the broad bundle will vary depending on how intensively a patient is treated for sHPT.
While the broad bundle might improve efficiency by reducing or eliminating incentives for unnecessarily intensive sFIPT treatment, it may also lead providers to avoid patients requiring more care or to provide less-than-appropriate sHPT therapy like calcium-binding agents.
The decrease in serum calcitriol is critical in the development of SHPT, and thus the inhibitory effect on renal calcitriol synthesis by increased FGF-23 maybe a key factor in the pathogenesis of SHPT.
* GlobalData anticipates the launch of new agents for the treatment of hyperphosphatemia and SHPT.
Will these treatments address the key unmet needs identified by KOLs?
The most recent Phase IIa data showed that the drug produced sustained reductions in parathyroid hormone, phosphorus, calcium and FGF-23, all recognised markers of SHPT.
The generation interval was 4.3 for the CHPPT scheme, 4.2 for MHPPT, and 3.8 for SHPT.
For the CHPPT and MHPPT schemes, proven bulls were supposed to be selected at age 5, but younger bulls (age 2 years) were also included in the progeny test.
The double-blind, randomized, placebo-controlled, multiple ascending dose study will assess the safety, tolerability and efficacy of multiple intravenous (IV) doses of KAI-4169 administered during hemodialysis in patients with SHPT.