What is the target range for parathyroid hormone (PTH) levels in patients with End-Stage Renal Disease (ESRD)?

From the Guidelines

The target range for parathyroid hormone (PTH) levels in patients with End-Stage Renal Disease (ESRD) should be 150-300 pg/mL. This range is based on the most recent and highest quality study available, which prioritizes morbidity, mortality, and quality of life as the outcome 1. The Kidney Disease: Improving Global Outcomes (KDIGO) 2017 clinical practice guideline update recommends treating patients with PTH values that are progressively increasing or persistently above the upper limit of normal, rather than basing treatment on a single elevated value.

Key Considerations

• The target range of 150-300 pg/mL is specifically recommended for ESRD patients on dialysis to maintain appropriate bone turnover while avoiding the extremes of either adynamic bone disease or severe secondary hyperparathyroidism.
• Maintaining PTH within this range helps balance the risks of renal osteodystrophy, vascular calcification, and other complications of mineral bone disorder in ESRD.
• Regular monitoring of PTH levels every 3-6 months is recommended for patients on dialysis, with more frequent testing if values are outside the target range or during treatment adjustments.
• Management typically involves controlling phosphate levels through dietary restrictions and phosphate binders, maintaining adequate vitamin D levels, and sometimes using calcimimetics like cinacalcet when PTH levels become significantly elevated.

Evidence-Based Recommendations

• The 2018 study published in the Annals of Internal Medicine provides the most recent and highest quality evidence for the target range of PTH levels in ESRD patients 1.
• The study recommends treating patients with PTH values that are progressively increasing or persistently above the upper limit of normal, rather than basing treatment on a single elevated value.
• The use of calcimimetics, calcitriol, and vitamin D analogues are acceptable first-line options in patients receiving dialysis, while the routine use of calcitriol or vitamin D analogues is not recommended in patients not receiving dialysis due to the increased risk for hypercalcemia.

From the FDA Drug Label

Cinacalcet (or placebo) was initiated at a dose of 30 mg once daily and titrated every 3 or 4 weeks to a maximum dose of 180 mg once daily to achieve an iPTH of ≤ 250 pg/mL The dose was not increased if a patient had any of the following: iPTH ≤ 200 pg/mL, serum calcium < 7.8 mg/dL, or any symptoms of hypocalcemia. Approximately 60% of patients with mild (iPTH ≥ 300 to ≤ 500 pg/mL), 41% with moderate (iPTH > 500 to 800 pg/mL), and 11% with severe (iPTH > 800 pg/mL) secondary HPT achieved a mean iPTH value of ≤ 250 pg/mL.

The target range for parathyroid hormone (PTH) levels in patients with End-Stage Renal Disease (ESRD) is ≤ 250 pg/mL for iPTH, with a lower limit of ≤ 200 pg/mL where the dose should not be increased 2.

• Mild disease: iPTH ≥ 300 to ≤ 500 pg/mL
• Moderate disease: iPTH > 500 to 800 pg/mL
• Severe disease: iPTH > 800 pg/mL

From the Research

PTH Acceptable Range for ESRD

The target range for parathyroid hormone (PTH) levels in patients with End-Stage Renal Disease (ESRD) is not explicitly stated in the provided studies. However, the studies suggest that elevated PTH levels are associated with increased fracture rates, cardiovascular disease, and mortality in ESRD patients 3.

Key Findings

• A study published in 1999 found that paricalcitol, a vitamin D analogue, effectively decreased PTH levels by about 60% over a 12-week period, with mean serum concentrations of calcium remaining within the normal range 4.
• Another study published in 2016 suggested that the serum concentration of PTH required for optimal bone health and reduced cardiovascular risk in ESRD patients remains elusive 3.
• A 2-year, single-center crossover study published in 2010 found that conversion from calcitriol to paricalcitol resulted in lower serum calcium, lower serum phosphorus, and reduced PTH levels 5.
• A review published in 2009 proposed a novel treatment framework in which calcimimetics are the primary therapy for suppressing parathyroid hormone production in patients with end-stage renal disease 6.
• A cross-sectional study published in 2018 found a significant positive correlation between PTH and phosphorous, potassium, and serum creatinine, while a significant negative correlation was found with calcium and corrected calcium 7.

PTH Levels in ESRD Patients

• The mean value of PTH in ESRD patients was found to be 173.93 ± 62.62 pg/mL, indicating increased levels of PTH to compensate for deranged mineral status 7.
• The studies suggest that PTH plays a crucial role in mineral metabolism and should be frequently assessed to prevent complications like bone disease and extra skeletal calcification, and decrease cardiac disease risk in ESRD patients 7.

Treatment of Secondary Hyperparathyroidism

• The management of secondary hyperparathyroidism in ESRD patients commonly involves vitamin D, either calcitriol or newer analogs, along with dietary phosphorus restriction and phosphate binding agents 5.
• Calcimimetics may be considered as an alternative to calcitriol in the treatment of patients who are undergoing maintenance hemodialysis for end-stage renal disease, as they have a decreased potential to induce hypercalcemia and hyperphosphatemia 4, 6.