A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01506947|
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Secondary Hyperparathyroidism Stage 5 Chronic Kidney Diseases||Drug: Paricalcitol Drug: Darbepoetin alfa||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients|
|Actual Study Start Date :||May 10, 2012|
|Actual Primary Completion Date :||April 7, 2016|
|Actual Study Completion Date :||April 7, 2016|
Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia.
Paricalcitol was administered by intravenous bolus. The initial dose was calculated according to the following formula:
[Paricalcitol (µg) = iPTH (pg/mL) / 80]. Subsequent doses were determined based on iPTH, calcium and phosphorus levels.
Drug: Darbepoetin alfa
Routine darbepoetin alfa use was allowed when transferrin saturation (TSAT) was ≥ 20% and ferritin ≥ 200 μg/L, and hemoglobin level < 11.5 g/dL. The initial dose was 0.25 to 0.75 µg/kg/week, and the maintenance dose was 0.13 to 0.35 µg/kg/week. Target hemoglobin level was between 10 to 11.5 g/dL.
- Mean Erythropoietin Dose Per Visit [ Time Frame: Baseline and Months 1, 2, 3, 4, 5 and 6 ]The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study. The mean EPO dosage per injection for each study month is reported.
- Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire [ Time Frame: Baseline and Month 6 ]The Medical Outcome Study Short Form 36-Item Health Survey (SF-36) is a self-administered questionnaire that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains. The domains include physical (physical functioning, role limitations due to physical health (role-physical), general health perceptions and pain) and mental domains (energy/fatigue (vitality), social functioning, emotional well-being (mental health), and role limitations due to emotional problems (role emotional)). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.
- Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
- Mean Calcium Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
- Mean Phosphorus Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
- Mean Alkaline Phosphatase Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
- Vitamin B12 Levels [ Time Frame: Baseline and month 6 ]
Vitamin B12 levels were categorized according to the following laboratory reference ranges:
Low: < 200 pg/mL Normal: 200 - 950 pg/mL High: > 950 pg/mL
- Folic Acid Levels [ Time Frame: Baseline and month 6 ]
Folic acid levels were categorized according to the following laboratory reference ranges:
Low: < 4.6 ng/mL Normal: 4.6 - 18.7 ng/mL High: > 18.7 ng/mL
- Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
- Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]
- Number of Participants With Adverse Events [ Time Frame: From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months. ]
Serious adverse events were any adverse events meeting any of the following criteria:
- An event that resulted in the death of a participant;
- An event that, in the opinion of the investigator, would have resulted in immediate fatality if medical intervention had not been taken (life-threatening);
- Resulted in an admission to the hospital for any length of time or prolonged hospital stay;
- An anomaly detected at or after birth, or any anomaly that results in fetal loss;
- An event that resulted in a condition that substantially interfered with the activities of daily living;
- An important medical event that may not be immediately life-threatening or result in death or hospitalization, but based on medical judgment may have jeopardized the participant and may have required medical or surgical intervention to prevent any of the outcomes listed above.
Adverse events were assessed by the investigator for possible relationship to study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506947
|Study Director:||Mahmut Gücük, MD||AbbVie|