Objective
This study assessed the risk of developing chronic kidney disease (CKD) and decline in estimated glomerular filtration rate (eGFR) over a period of up to 5 years in adult patients with chronic hypoparathyroidism treated with recombinant human parathyroid hormone (1‐84) (rhPTH[1‐84]) compared with a historical control cohort of patients not treated with rhPTH(1‐84).
Design
Retrospective cohort study of patients with chronic hypoparathyroidism treated with rhPTH(1‐84) derived from the REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309) and HEXT (NCT01199614, and its continuation study NCT02910466) clinical trials and a historical control cohort who did not receive PTH selected from an electronic medical record database.
Patients
One hundred and eighteen patients treated with rhPTH(1‐84) and 497 patient controls.
Measurements
Incident CKD was defined as ≥2 eGFR measurements <60 ml/min/1.73 m2 ≥3 months apart during the study and a sustained eGFR decline of ≥30% from baseline.
Results
Over the 5‐year period, Kaplan–Meier analyses showed that rhPTH(1‐84)‐treated patients had a significantly lower risk of developing CKD (log‐rank p = .002) and a lower risk for a sustained eGFR decline ≥30% from baseline (log‐rank p < .001) compared with patients in the control cohort. In adjusted analyses, patients in the rhPTH(1‐84)‐treated cohort had a 53% lower risk of developing CKD (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.25–0.87) and a 65% lower risk for sustained eGFR decline ≥30% from baseline (HR, 0.35; 95% CI, 0.13–0.89) compared with controls.
Conclusions
Patients with chronic hypoparathyroidism treated with rhPTH(1‐84) in long‐term clinical trials had a significantly lower risk of developing CKD compared with patients in a historical control cohort not treated with rhPTH(1‐84).