Rockwell Medical(RMTI)
WIXOM, MI
Biotechnology3 H-1B visas (FY2023)Focus: Dialysis Products
Rockwell Medical is a life sciences company focused on Dialysis Products.
Nephrology
Funding Stage
PUBLIC
Open Jobs
0
Products & Portfolio (4)
CALCITRIOL
calcitriol
Post-LOE
INJECTION · INJECTABLE
CLINICAL PHARMACOLOGY Man's natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D 3 (cholecalciferol). Vitamin D 3 must be metabolically activated in the liver and the kidney before it is fully active as a regulator of calcium and phosphorus metabolism at target tissues. The initial transformation of vitamin D 3 is catalyzed by a vitamin D 3 -25-hydroxylase enzyme (25-OHase) present in the liver, and the product of this reaction is 25-hydroxyvitamin D 3 [25-(OH)D 3 ]. Hydroxylation of 25-(OH)D 3 occurs in the mitochondria of kidney tissue, activated by the renal 25-hydroxyvitamin D 3 -1 alpha-hydroxylase (alpha-OHase), to produce 1,25-(OH) 2 D 3 (calcitriol), the active form of vitamin D 3 . Endogenous synthesis and catabolism of calcitriol, as well as physiological control mechanisms affecting these processes, play a critical role regulating the serum level of calcitriol. Physiological daily production is normally 0.5 to 1.0 mcg and is somewhat higher during periods of increased bone synthesis (e.g., growth or pregnancy). Pharmacodynamics The two known sites of action of calcitriol are intestine and bone. A calcitriol receptor-binding protein appears to exist in the mucosa of human intestine. Additional evidence suggests that calcitriol may also act on the kidney and the parathyroid glands. Calcitriol is the most active known form of vitamin D 3 in stimulating intestinal calcium transport. In acutely uremic rats calcitriol has been shown to stimulate intestinal calcium absorption. The kidneys of uremic patients cannot adequately synthesize calcitriol, the active hormone formed from precursor vitamin D. Resultant hypocalcemia and secondary hyperparathyroidism are a major cause of the metabolic bone disease of renal failure. However, other bone-toxic substances which accumulate in uremia (e.g., aluminum) may also contribute. The beneficial effect of calcitriol in renal osteodystrophy appears to result from correction of hypocalcemia and secondary hyperparathyroidism. It is uncertain whether calcitriol produces other independent beneficial effects. Calcitriol treatment is not associated with an accelerated rate of renal function deterioration. No radiographic evidence of extraskeletal calcification has been found in predialysis patients following treatment. The duration of pharmacologic activity of a single dose of calcitriol is about 3 to 5 days. Pharmacokinetics Absorption Calcitriol is rapidly absorbed from the intestine. Peak serum concentrations (above basal values) were reached within 3 to 6 hours following oral administration of single doses of 0.25 to 1.0 mcg of calcitriol. Following a single oral dose of 0.5 mcg, mean serum concentrations of calcitriol rose from a baseline value of 40.0 ± 4.4 (SD) pg/mL to 60.0 ± 4.4 pg/mL at 2 hours, and declined to 53.0 ± 6.9 at 4 hours, 50 ± 7.0 at 8 hours, 44 ± 4.6 at 12 hours, and 41.5 ± 5.1 at 24 hours
the management of secondary hyperparathyroidismresultant metabolic bone disease in patients with moderate to severe chronic renal failure (C cr 15 to 55 mL/min) not yet on dialysisthe management of hypocalcemia+4 more
2003
30
TRIFERIC
ferric pyrophosphate citrate
Peak
INTRAVENOUS · SOLUTION
2015
8
TRIFERIC
ferric pyrophosphate citrate
Peak
INTRAVENOUS · POWDER
2016
8
TRIFERIC AVNU
ferric pyrophosphate citrate
Peak
INTRAVENOUS · SOLUTION
2020
8
Pipeline & Clinical Trials
soluble ferric pyrophosphate
End Stage Renal Disease (ESRD)Clinical Trials (1)
NCT00604565Delivery of Soluble Ferric Pyrophosphate (SFP) Via the Dialysate to Maintain Iron Balance in Hemodialysis Patients
N/ATriferic
Peritoneal Dialysis (PD)Clinical Trials (1)
NCT02909153Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis
Phase 1soluble ferric pyrophosphate
Kidney Failure, Chronic Therapy; HemodialysisClinical Trials (1)
NCT01920854A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
Phase 1Triferic
End Stage Renal DiseaseClinical Trials (1)
NCT02636049Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers
Phase 1Triferic
End Stage Renal DiseaseClinical Trials (1)
NCT02739100Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Phase 1Phase 1
Clinical Trials (1)
NCT02767128Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers
Phase 1Soluble Ferric Pyrophosphate
Kidney FailureClinical Trials (1)
NCT01894906Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients
Phase 1/2Triferic
End Stage Renal DiseaseClinical Trials (1)
NCT04409132Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
Phase 1/2Triferic
End Stage Renal DiseaseClinical Trials (1)
NCT04042324A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
Phase 1/2Triferic
End Stage Renal DiseaseClinical Trials (1)
NCT02595437Triferic Pediatric Pharmacokinetic Protocol
Phase 1/2Triferic
End Stage Renal DiseaseClinical Trials (1)
NCT03303144Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Phase 1/2Soluble Ferric Pyrophosphate in liquid bicarbonate
End Stage Renal DiseaseClinical Trials (1)
NCT01286012Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
Phase 2Triferic AVNU
Iron Deficiency AnemiaClinical Trials (1)
NCT05110768Treatment of (IDA) by (FPC) Delivered Via Infusion Pump in Patients Receiving Home Infusion Therapy
Phase 2Standard Bicarbonate Solution
End-Stage Renal Disease (ESRD)Clinical Trials (1)
NCT00548249Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
Phase 2Fer-In-Sol
Iron-Refractory Iron-Deficiency AnemiaClinical Trials (1)
NCT02905981Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol
Phase 2Phase 3
Clinical Trials (1)
NCT01503021Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
Phase 3Soluble Ferric Pyrophosphate
Renal Failure Chronic Requiring HemodialysisClinical Trials (1)
NCT01322347Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)
Phase 3Soluble Ferric Pyrophosphate
Renal Failure Chronic Requiring HemodialysisClinical Trials (1)
NCT01320202Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
Phase 3Triferic
End Stage Renal DiseaseClinical Trials (1)
NCT04239391Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)
Phase 3Triferic AVNU
End Stage Renal DiseaseClinical Trials (1)
NCT04689932Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Phase 4Open Jobs (0)
No open positions listed yet. Check their careers page directly.
Interview Prep Quick Facts
Portfolio: 4 approved products, 20 clinical trials
Top TAs: Endocrinology, Nephrology
H-1B (2023): 3 approvals
SEC Filings: 2 available
Portfolio Health
Peak3 (75%)
Post-LOE1 (25%)
4 total products
Hiring Trend
Stable
0
Open Roles
+0
Added
-0
Filled/Removed
Based on last 3 crawl cycles
Visa Sponsorship
Sponsors Work Visas
H-1B Petitions (FY2023)
3
Approved
0
Denied
100%
Rate
Source: USCIS H-1B Employer Data Hub