Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience

The time to attain the first lower iPTH levels was considered as the time from the date of oral paricalcitol treatment onset until the date when any of the following conditions were initially met: a 30% reduction from iPTH levels prior to treatment onset had been achieved, for patients who were still outside the target range; or iPTH levels equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL; CKD Stage 5: ≤ 300 pg/mL).

The effect was considered sustainable if: the participant's intact parathormone (iPTH) value remained equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL); or iPTH levels continued to decrease 30% from the previous available measurement.

Number of participants with iPTH levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines at each study measurement after oral paricalcitol treatment onset. K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.

Normal serum calcium range was 8.4-10.2 mg/dL.

Normal serum phosphorus range was 2.7-4.6 mg/dL.

The values "-, Trace, +, ++, and +++" are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.

The values "-, Trace, +, ++, and +++" are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.

The HbA1c normal range was 4.3-6.1%.

In order to establish the safety profile of oral paricalcitol in daily clinical practice, non-serious adverse events (nSAEs) and serious adverse events (SAEs) were collected during the course of the study. An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.

Change in CKD stage throughout the study period was assessed by the estimated glomerular filtration rate (eGFR) levels recorded by the physicians at each study time point. Classification of eGFR into CKD stages as follows: CKD stage 2: 60-89 mL/min/1.73m^2; CKD stage 3: 30-59 mL/min/1.73m^2; CKD stage 4: 15-29 mL/min/1.73m^2; CKD stage 5: <15 mL/min/1.73/m^2. Table presents the number of participants by stage at each study visit.

The eGFR normal range was 90-120 mL/min/1.73m^2.

The alanine aminotransferase normal range was 11-43 IU/L.

The aspartate aminotransferase normal range was 11-38 IU/L.

The creatinine normal range was 0.6-1.4 mg/dL.

The urea normal range was 10-50 mg/dL.

The alkaline phosphatase normal range was 40-129 IU/L.

The total cholesterol normal range was 130-200 mg/dL.

The normal range for triglycerides was 0-200 mg/dL.

The LDL-C normal range was 0-150 mg/dL.

The HDL-C normal range was 35-90 mg/dL.

The CRP normal range was 0-0.6 mg/dL.

The homocysteine normal range 3.5-20 μmol/L.