The prevalence of chronic kidney disease (CKD) in the adult population is estimated to 10%. CKD increases risk of bone fractures, cardiovascular disease and death. The main role of parathyroid hormone (PTH) is to regulate mineral metabolism, including the calcium and phosphate homeostasis. PTH increases as the kidney function declines, and at end stage kidney disease almost all patients have disturbances in the mineral metabolism. Decreasing bone mineral density is associated with risk of fracture, both in background population and in patients with CKD.
For decades, treatment with activated vitamin D, phosphate binders, and calcium supplements has been used for patients with chronic kidney disease and elevated parathyroid hormone, but treatment targets have varied greatly over the years, reflecting the lack of randomized clinical trials with clinical important end points.
The purpose of The REPAIR-CKD trial is to determine if treatment of hyperparathyroidism improves the bone mineral density in patients with chronic kidney disease.
During this trial it will also be evaluated if it is feasible to obtain a difference in PTH levels when targeting two different levels of PTH.
Further this trial will explore if a difference in PTH influences on arterial stiffness, muscle mass, muscle function, bone histology and health related quality of life.
≥50 years of age at screening
CKD G4-5nonD (eGFR < 30 mL/min/1.73m2) based on local laboratory assessment of serum creatinine and eGFR estimated by the CKD-EPI formula)
Plasma PTH > upper normal limit of local laboratory reference range (> 8,5µmol/L) and/or treated with active vitamin D (Alphacalcidol) or calcimetics (Cinacalcet) initially
Written informed consent
Patients who have received a kidney transplant
Patients receiving treatment with specific anti-osteoporosis medication (denosumab/bisphosphonates) (because of the profound effect on calcium/phosphate fluxes and BMD)
Parallel
Treat to target
Other interventionParticipants will receive treatment from a "toolbox" depending on the situation to reach the PTH target. Available medication is mirroring what is used in the outpatient clinic setting already (native vitamin D, activated vitamin D, phosphate binders, calcimetics).
Difference in percent change in bone mineral density (BMD) between the treatment groups.
Measured with DEXA-scan
Difference in follow-up BMD between treatment groups
Measured with DEXA-scan
Difference in follow-up arterial stiffness between the treatment groups
Measured as pulse wave velocity by applanation tonometry with Sphygmocor
Difference in follow-up muscle mass between the treatment groups
Measured as appendicular lean body mass (DEXA-scan) as an approximation of muscle mass
Difference in follow-up hand grip strenght between the treatment groups
Muscle function will be assessed by different measures including hand grip strenght.
The feasibility to obtain a differential PTH level of at least 0.5 times the upper limit of normal between the two groups will be determined
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Herlev Hospital
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
