KDIGO. PTH and Vitamin D
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- Prudence Sharlene O’Connor’
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1 3.1.1We recommend monitoring serum levels of calcium, phosphorus, PTH, and alkaline phosphatase ac?vity beginning in CKD stage 3 (1C). In children, we suggest such monitoring beginning in CKD stage 2 (2D). REVISE: 1. Consider a change for adults to 3B Basis: 3A captures a very large popula?on of adults, many of whom are elderly, with stable renal func?on VOTE: 16/16 2. Consider a change In children to 3A VOTE: 1/1
2 3.1.2 In pa?ents with CKD stages 3 5D, it is reasonable to base the frequency of monitoring serum calcium, phosphorus, and PTH on the presence and magnitude of abnormali?es, and the rate of progression of CKD (not graded). AGREE but consider star?ng at 3B adults, 3A children
3 3.1.2 Reasonable monitoring intervals would be: In CKD stage 3: for serum calcium and phosphorus, every 6 12 months; and for PTH, based on baseline level and CKD progression. AGREE In CKD stage 4: for serum calcium and phosphorus, every 3 6 months; and for PTH, every 6 12 months. In stage 4 PTH every 3-12 months according to baseline values and trends
4 3.1.2 Reasonable monitoring intervals would be: In CKD stage 5, including 5D: for serum calcium and phosphorus, every 1 3 months; and for PTH, every 3 6 months. Sugges?on: add according to baseline values and trends In CKD stages 4 5D: for alkaline phosphatase ac?vity, every 12 months, or more frequently in the presence of elevated PTH (see Chapter 3.2). REVISE: (new evidence) Sugges?on: measure ALP or preferably b- ALP when available Because these are independent predictors of bone turnover, they could be measured in the presence or absence of an elevated PTH b- ALP is par?cularly relevant if ALP and other LFTs are elevated
5 SUGGESTIONS FOR FUTURE RESEARCH Assess other biomarkers of bone turnover, par?cularly resorp?on markers including TRAcP- 5b and serum CTX; We require further informa?on on the accumula?on of markers such as CTX and P1NP in CKD Correla?on of P1NP with bone histomorphometry in CKD would be useful, in view of its wide use, standardiza?on of the assay and its availability.
6 3.1.3 In pa?ents with CKD stages 3 5D, we suggest that 25(OH)D (calcidiol) levels might be measured, and repeated tes?ng determined by baseline values and therapeu?c interven?ons (2C). REVISE; remove might There is adequate evidence, including in people with CKD, that very low values of 25OHD are harmful to bone health and may have wider effects
7 3.1.3 We suggest that vitamin D deficiency and insufficiency be corrected using treatment strategies recommended for the general popula?on (2C). REVISE; Popula?on specificity and new data. Pa?ents with CKD differ from the general popula?on. Appropriate supplementa?on might beber reflect the management of vitamin D deficient or insufficient pa?ents with non CKD osteoporosis In this popula?on, 25OHD values 30 ng/ml (75 nmol/l) may be an appropriate target
8 3.1.3 We suggest that vitamin D deficiency and insufficiency be corrected using treatment strategies recommended for the general popula?on (2C). Dosing regimens have now been tested in pa?ents with CKD: low dose eg. 800 IU/day cholecalciferol/ ergocalciferol are effec?ve in reaching targets, as are weekly and monthly doses of cholecalciferol, with doses to 50,000 IU. General popula?on data suggests high dosees at increased intervals (such as 500,000 IU yearly) should be avoided Vitamin D2 (ergo) and D3 (chole) treatments may require different dosing and dose frequency.
9 SUGGESTIONS FOR FUTURE RESEARCH Assessment of bioavailable D in people with CKD. Data in this area will become available soon.
10 4.2.1 In pa?ents with CKD stages 3 5 not on dialysis, the op?mal PTH level is not known. However, we suggest that pa?ents with levels of intact PTH (ipth) above the upper normal limit of the assay are first evaluated for hyperphosphatemia, hypocalcemia, and vitamin D deficiency (2C). AGREE
11 4.2.1 It is reasonable to correct these abnormali?es with any or all of the following: reducing dietary phosphate intake and administering phosphate binders, calcium supplements, and/or na?ve vitamin D (not graded). REVISE: new data Agreement with vitamin D supplementa?on. Agreement with dietary P reduc?on. Discussion of phosphate addi?ves to food and differences in absorp?on dependent on food types.
12 4.2.1 It is reasonable to correct these abnormali?es with any or all of the following: reducing dietary phosphate intake and administering phosphate binders, calcium supplements, and/or na?ve vitamin D (not graded). REVISE: new data Ca supplements: ensure adequate dietary calcium, and if inadequate, cau?on with supplemental calcium, par?cularly as CKD progresses Opinion of the group that the cau?ous use of phosphate binders should be individualized. Available phosphate binders in CKD 3-5 will ohen be calcium- based.
13 4.2.2 In pa?ents with CKD stages 3 5 not on dialysis, in whom serum PTH is progressively rising and remains persistently above the upper limit of normal for the assay despite correc?on of modifiable factors, we suggest treatment with calcitriol or vitamin D analogs (2C). REVISE: new data PTH values above the upper normal range may be appropriate. Normal PTH values in CKD 4-5 may induce LBT. However very high PTH values in pre dialysis pa?ents will increase later risk of shpt Calcitriol will increase absorp?on of Ca and P
14 4.2.2 In pa?ents with CKD stages 3 5 not on dialysis, in whom serum PTH is progressively rising and remains persistently above the upper limit of normal for the assay despite correc?on of modifiable factors, we suggest treatment with calcitriol or vitamin D analogs (2C). REVISE: new data This needs to be seen as a component in a con?nuum of management rather than an isolated treatment More appropriately: Treatment with calcitriol or vitamin D analogs might be used
15 4.2.3 In pa?ents with CKD stage 5D, we suggest maintaining ipth levels in the range of approximately two to nine?mes the upper normal limit for the assay (2C). We suggest that marked changes in PTH levels in either direc?on within this range prompt an ini?a?on or change in therapy to avoid progression to levels outside of this range (2C). Agree 14/16, however REVISE: new data available or soon to be available including COSMOS and EVOLVE Comments and concerns: 9?mes is too high the range is too wide
16 4.2.3 In pa?ents with CKD stage 5D, we suggest maintaining ipth levels in the range of approximately two to nine?mes the upper normal limit for the assay (2C). We suggest that marked changes in PTH levels in either direc?on within this range prompt an ini?a?on or change in therapy to avoid progression to levels outside of this range (2C). Concerns regarding effects on bone and progression of parathyroid hyperplasia Concerns that acceptance of high values may reduce the efficacy of treatment strategies
17 4.2.3 In pa?ents with CKD stage 5D, we suggest maintaining ipth levels in the range of approximately two to nine?mes the upper normal limit for the assay (2C). We suggest that marked changes in PTH levels in either direc?on within this range prompt an ini?a?on or change in therapy to avoid progression to levels outside of this range (2C). Funding issues if high values of PTH are acceptable Concerns at the use of fold rather than a numerical value; however, we agreed that due to the variety of assays, this was acceptable providing there was assay standardisa?on A new paediatric range should be defined
18 4.2.4 In pa?ents with CKD stage 5D and elevated or rising PTH, we suggest calcitriol, or vitamin D analogs, or calcimime?cs, or a combina?on of calcimime?cs and calcitriol or vitamin D analogs be used to lower PTH (2B). AGREE Discussion: Control of P should be added These strategies reduce the risk of PTx Calcitriol and analogs reduce the risk of worsening bone architecture Management is sequen?al; considera?on of phosphate control before use fo VDRAs; although this is addressed in the next dot point
19 4.2.4 It is reasonable that the ini?al drug selec?on for the treatment of elevated PTH be based on serum calcium and phosphorus levels and other aspects of CKD MBD (not graded). It is reasonable that calcium or non- calcium- based phosphate binder dosage be adjusted so that treatments to control PTH do not compromise levels of phosphorus and calcium (not graded). AGREE with both dot points
20 4.2.4 In pa?ents with CKD stage 5D and elevated or rising PTH, we suggest calcitriol, or vitamin D analogs, or calcimime?cs, or a combina?on of calcimime?cs and calcitriol or vitamin D analogs be used to lower PTH (2B). We recommend that, in pa?ents with hypercalcemia, calcitriol or another vitamin D sterol be reduced or stopped (1B). AGREE: however sugges?on to also consider reduc?on of any Ca supplementa?on
21 4.2.4 In pa?ents with CKD stage 5D and elevated or rising PTH, we suggest calcitriol, or vitamin D analogs, or calcimime?cs, or a combina?on of calcimime?cs and calcitriol or vitamin D analogs be used to lower PTH (2B). We suggest that, in pa?ents with hyperphosphatemia, calcitriol or another vitamin D sterol be reduced or stopped (2D). AGREE: but con?nue na2ve vitamin D and dietary modifica?on
22 4.2.4 In pa?ents with CKD stage 5D and elevated or rising PTH, we suggest calcitriol, or vitamin D analogs, or calcimime?cs, or a combina?on of calcimime?cs and calcitriol or vitamin D analogs be used to lower PTH (2B). We suggest that, in pa?ents with hypocalcemia, calcimime?cs be reduced or stopped depending on severity, concomitant medica?ons, and clinical signs and symptoms (2D) AGREE
23 4.2.4 In pa?ents with CKD stage 5D and elevated or rising PTH, we suggest calcitriol, or vitamin D analogs, or calcimime?cs, or a combina?on of calcimime?cs and calcitriol or vitamin D analogs be used to lower PTH (2B). We suggest that, if the intact PTH levels fall below two?mes the upper limit of normal for the assay, calcitriol, vitamin D analogs, and/or calcimime?cs be reduced or stopped (2C). AGREE but REVISE; Addi?onal sources of calcium including supplemental calcium, phosphate binder calcium and dialysate Ca need to be considered
24 SUGGESTIONS FOR POTENTIAL NEW GUIDELINES Although numerical values will differ, biointact (PTH 1-84) assays for PTH may be used interchangeably with intact assays when implemen?ng these guidelines
25 4.2.5 In pa?ents with CKD stages 3 5D with severe hyperparathyroidism (HPT) who fail to respond to medical/pharmacological therapy, we suggest parathyroidectomy (2B). AGREE: comment that severe unremimng may be a more appropriate term
26 5.2 In pa?ents aher the immediate post- kidney- transplant period, it is reasonable to base the frequency of monitoring serum calcium, phosphorus, and PTH on the presence and magnitude of abnormali?es, and the rate of progression of CKD (not graded). AGREE: discussion point that aher the immediate post transplant period might need beber defini?on; e.g. 3 months
27 5.2 Reasonable monitoring intervals would be: In CKD stages 1 3T, for serum calcium and phosphorus, every 6 12 months; and for PTH, once, with subsequent intervals depending on baseline level and CKD progression. AGREE: Comment; Baseline is unclear; for PTH, the pre transplant value is ohen indica?ve of post transplant levels and will influence frequency of post transplant monitoring.
28 5.2 Reasonable monitoring intervals would be: In CKD stage 4T, for serum calcium and phosphorus, every 3 6 months; and for PTH, every 6 12 months. REVISE: This should be concordant with earlier CKD- 4 recommenda?on; for PTH, 3-12 months dependent upon baseline values and trends
29 5.2 In CKD stages 3 5T, measurement of alkaline phosphatases annually, or more frequently in the presence of elevated PTH (see Chapter 3.2). REVISE; As in the CKD guideline, the current guideline suggests ALP measurement as an adjunct to PTH assessment; However ALP/BALP/and other markers may be useful in conjunc?on with PTH, but also as a guide to management of post transplant bone, par?cularly when bisphosphonates or other therapies are being considered.
30 5.3 In pa?ents with CKD stages 1 5T, we suggest that 25(OH)D (calcidiol) levels might be measured, and repeated tes?ng determined by baseline values and interven?ons (2C). REVISE: This should be concordant with earlier CKD recommenda?on: tes?ng should be performed. Discussion that values of 25OHD are ohen insufficient and deficient in this pa?ent group, and can fall rapidly aher transplanta?on.
31 5.4 In pa?ents with CKD stages 1 5T, we suggest that vitamin D deficiency and insufficiency be corrected using treatment strategies recommended for the general popula?on (2C). REVISE: Management of low vitamin D levels in this popula?on will require different supplementa?on regimens than those applicable to the general popula?on
32 SUGGESTIONS FOR POTENTIAL NEW GUIDELINES Guidelines do not currently address the use of monitoring sex steroids, assessment of amenorrhea in pre menopausal women, female or male hormonal replacement or lifestyle factors aher transplanta?on.
33 SUGGESTIONS FOR POTENTIAL NEW GUIDELINES An assessment of the grounds to rou?nely use FGF 23 as a marker for CKD- MBD
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