Abstract
Background and Aims
The 2017 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease-Mineral Bone Disorder (CKD-MBD) guidelines inform clinical practice for the management of secondary hyperparathyroidism (SHPT) internationally; however, many recommendations lacked high or moderate clinical evidence as defined by KDIGO. An expert panel was convened to establish clinical consensus for the current management of SHPT in the United States (US).
Method
The panel comprised 10 US healthcare providers (HCPs; [6 nephrologists, 1 surgeon, 1 nurse practitioner, 1 pharmacist, 1 dietician]) and 1 patient. HCP panelists participated in a modified Delphi process over 3 phases, addressing 126 questions based on a review of the literature and published guidelines. The threshold for consensus was 66%. In phases 1 and 2, panelists anonymously completed electronic surveys considering a ‘typical’ patient with SHPT unless otherwise specified. In phase 1, panelists answered 126 questions based on their own knowledge and experiences. In phase 2, panelists were reminded of their answers to closed-ended questions that did not achieve consensus in phase 1 and were asked if they would change their responses in light of the most common response. For open-ended questions, they were asked if they agreed with summary statements that captured the most common answers. Phase 3 was an unblinded virtual meeting where panelists reviewed the consensus reached in phases 1 and 2, and through active discussion, resolved those questions that had not reached consensus. The patient completed a separate electronic survey, which complemented key points in the HCP survey, and provided perspective during the virtual meeting.
Results
All 11 panelists completed the entire modified Delphi process. Sixty-three out of 126 (50%) and 116/126 (92.1%) questions reached consensus or addressed practice-specific information not requiring consensus by the end of phase 1 and 2, respectively; all questions reached consensus by the end of phase 3, including modification of 2 questions and the addition of 1 question. The panel unanimously agreed that SHPT treatment is often started too late and suggested additional markers for early identification of patients requiring treatment are needed. Serum levels of calcium, phosphate, and parathyroid hormone (PTH) should be monitored starting at CKD stage G3a at intervals of every 6 months, 3–6 months for CKD G3b, and at least every 3 months at CKD G4 and above. Thresholds for interventions could not be defined in absolute terms for all patients due to patient-and practice-specific factors. However, in patients on dialysis, serum levels of phosphate > 5.5 mg/dL (1.8 mmol/L) and calcium > 9.5 mg/dL (2.4 mmol/L), warrant increased monitoring and consideration of therapeutic interventions. Serum intact PTH > 300 pg/mL (32 pmol/L) typically indicates a need for SHPT treatment, with a consensus preferred target of 150–300 pg/mL (16–32 pmol/L); patients on dialysis were considered out of PTH target at ≥ 8 times the upper limit of normal (> 520 pg/mL [55 pmol/L] intact PTH). HCPs were concerned about vascular calcification in all patients with CKD 3a–G5D. The panel reached consensus on the use of several SHPT interventions, including a consensus preference for the intravenous calcimimetic etelcalcetide over the oral calcimimetic cinacalcet in appropriate in-center dialysis patients requiring PTH-lowering therapy; cinacalcet was agreed to be first-line therapy in appropriate patients on home dialysis (Table 1). Factors such as formularies and dialysis center protocols were recognized to influence therapeutic choices.
Conclusion
Ten US HCPs reached consensus on many aspects of SHPT management, further defining therapeutic strategies and highlighting the need to be proactive. While the panel expressed evidenced-based preferences for certain therapies, factors such as cost and dialysis center protocols may affect decision making.
The whole-PTH/intact-PTH ratio is a useful predictor of severity of secondary hyperparathyroidism