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To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Erythropoietin Dose Per Visit | 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. | Baseline and Months 1, 2, 3, 4, 5 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire | 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. |
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Inclusion Criteria: A subject will only be included if all the following entry criteria are met:
Exclusion Criteria:
A subject will be excluded from the study if he/she meets any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmut Gücük, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26778412 | Background | Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3. |
| Label | URL |
|---|---|
| Related Info | View source |
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This study was conducted at 7 centers in Turkey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. |
|
| Baseline and Month 6 |
| Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6 | Baseline and Month 6 |
| Mean Calcium Level at Baseline and Month 6 | Baseline and Month 6 |
| Mean Phosphorus Level at Baseline and Month 6 | Baseline and Month 6 |
| Mean Alkaline Phosphatase Level at Baseline and Month 6 | Baseline and Month 6 |
| Vitamin B12 Levels | 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 | Baseline and month 6 |
| Folic Acid Levels | 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 | Baseline and month 6 |
| Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6 | Baseline and Month 6 |
| Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6 | Baseline and Month 6 |
| Number of Participants With Adverse Events | Serious adverse events were any adverse events meeting any of the following criteria:
Adverse events were assessed by the investigator for possible relationship to study drug. | From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months. |
| COMPLETED |
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| NOT COMPLETED |
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The per-protocol analysis set which included participants who completed the study according to the protocol. One patient was enrolled into the study under protocol version 1.0 and was not included in the per-protocol analysis set due to subsequent major changes to the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Erythropoietin Dose Per Visit | 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. | Per-protocol analysis set with EPO dosage available at all visits. | Posted | Mean | Standard Deviation | µg | Baseline and Months 1, 2, 3, 4, 5 and 6 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire | 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. | Per-protocol analysis set | Posted | Mean | Standard Deviation | units on a scale | Baseline and Month 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6 | Per-protocol analysis set with available data at each time point. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Calcium Level at Baseline and Month 6 | Per-protocol analysis set with available data at each time point. | Posted | Mean | Standard Deviation | mg/mL | Baseline and Month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Phosphorus Level at Baseline and Month 6 | Participants who completed the study with available data at each time point. | Posted | Mean | Standard Deviation | mg/mL | Baseline and Month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Alkaline Phosphatase Level at Baseline and Month 6 | Per-protocol analysis set with available data at each time point. | Posted | Mean | Standard Deviation | U/L | Baseline and Month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Vitamin B12 Levels | 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 | Per-protocol analysis set with available data at each time point. | Posted | Count of Participants | Participants | Baseline and month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Folic Acid Levels | 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 | Per-protocol analysis set with available data at each time point. | Posted | Count of Participants | Participants | Baseline and month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6 | Per-protocol analysis set with available data at each time point. | Posted | Mean | Standard Deviation | mg/mL | Baseline and Month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6 | Per-protocol analysis set with available data at each time point. | Posted | Mean | Standard Deviation | kRU/L | Baseline and Month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Serious adverse events were any adverse events meeting any of the following criteria:
Adverse events were assessed by the investigator for possible relationship to study drug. | The safety population included all participants who enrolled. | Posted | Number | participants | From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months. |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paricalcitol | 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. | 11 | 65 | 1 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrectomy | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Parathyroidectomy | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Renal transplant | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute Respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Stools watery | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoconcentration | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Title | Measurements |
|---|---|
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| Month 3 |
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| Month 4 |
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| Month 5 |
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| Month 6 |
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| Units | Counts |
|---|---|
| Participants |
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