Only for Stage 3 is it good news.
Wrong.
RAYALDEE is indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease.
KDIGO 4.2.2: In adult patients with CKD G3a–G5 not on dialysis, we suggest that calcitriol and vitamin D analogs not be routinely used (2C). It is reasonable to reserve the use of calcitriol and vitamin D analogs for patients with CKD G4–G5 with severe and progressive hyperparathyroidism (Not Graded).
RAYALDEE is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis. Currently, OPKO and Vifor Fresenius Medical Care Renal Pharma are currently jointly developing RAYALDEE® for dialysis patients.
Below shows the five stages of CKD and GFR for each stage:
Stage 1 with normal or high GFR (GFR > 90 mL/min)
Stage 2 Mild CKD (GFR = 60-89 mL/min)
Stage 3A Moderate CKD (GFR = 45-59 mL/min)
Stage 3B Moderate CKD (GFR = 30-44 mL/min)
Stage 4 Severe CKD (GFR = 15-29 mL/min)
Stage 5 End Stage CKD (GFR <15 mL/min)
KDIGO 4.2.4. In patients with CKD G5D and elevated or rising PTH, we suggest calcitriol, or vitamin D analogs, or calcimimetics, or a combination of calcimimetics and calcitriol or vitamin D analogs be used to lower PTH (2B).
This is good news for Rayaldee and it's intended indications on stage 3 or 4 chronic kidney disease, nuff said.