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NCT Number: NCT01506947

A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.

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Key information

Conditions

Moderate to Severe Secondary Hyperparathyroidism Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Stage 5 Chronic Kidney Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A subject will only be included if all the following entry criteria are met:

  • Patients ≥ 18 years of age
  • Stage 5 chronic kidney disease (CKD) patients receiving hemodialysis and with moderate to severe secondary hyperparathyroidism (SHPT)
  • Patients with anemia due to renal insufficiency but who are iron replete:; Transferrin saturation (TSAT) > 20% and Ferritin levels > 200 ng/mL and requiring treatment with erythropoietin (EPO)
  • Patients with vitamin B levels > lower limit of normal (LLN) and folic acid levels > LLN
  • Patients treated only with intravenous calcitriol for at least 6 months
  • Patients with serum intact parathyroid hormone (iPTH) level > 500 pg/mL
  • Patients with calcium phosphate product (Ca × PO4) < 65 mg²/dL²
  • Patients willing to sign "written informed consents" before participating in any the study related activity.
  • Patients with phosphorus levels < 6.5 mg/dL and calcium levels < 11.2 mg/dL

Exclusion criteria

A subject will be excluded from the study if he/she meets any of the following criteria:

  • Patients who have known hypersensitivity and/or toxicity to vitamin D metabolites and/or to paricalcitol and/or to other product ingredients.
  • Patients who have participated in a clinical study within the last month.
  • Patients whose previous concomitant medication and laboratory data for 6 months prior to the baseline visit are not available.
  • Patients with known contraindication to selective Vitamin D receptor activators (VDRAs) according to the Summary of Product Characteristics (SmPC).
  • Pregnancy, breast-feeding or planning a pregnancy within next 6 months after enrollment. Sexually active female patients not accepting appropriate contraceptive methods during the course of the study will also be excluded.
  • Hypertensive and diabetic patients who are not on an optimal and steady medication regimen for more than 30 days.
  • Patients with microcytic (mean corpuscular volume [MCV] < 80 fL) and macrocytic (MCV > 100 fL) anemia at screening that may be caused by diseases such as for microcytic anemias - Iron Deficiency, Thalassemias, Anemia of Chronic Disease, Copper Deficiency, Zinc poisoning, Sideroblastic Anemia, macrocytic anemias -ethanol abuse, myelodysplastic syndromes, acute myeloid leukemias, reticulocytosis, drug induced anemia, liver disease.

Treatment and study plan

Paricalcitol

Drug

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.

Other names: ABT-358, Zemplar

darbepoetin alfa

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6

    Time frame: Baseline and Month 6

  3. Mean Calcium Level at Baseline and Month 6

    Time frame: Baseline and Month 6

  4. Mean Phosphorus Level at Baseline and Month 6

    Time frame: Baseline and Month 6

  5. Mean Alkaline Phosphatase Level at Baseline and Month 6

    Time frame: Baseline and Month 6

  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

  7. 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

  8. Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6

    Time frame: Baseline and Month 6

  9. Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6

    Time frame: Baseline and Month 6

  10. 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.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2012
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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