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Repeated-dose Safety, Efficacy, PK and PD of CTAP101, IR Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With SHPT, CKD 3-4 and VDI

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: NCT03588884
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Brief Summary:
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Due to Renal Causes Vitamin D Deficiency CKD Stage 3 CKD Stage 4 Drug: Calcifediol Oral Capsule Drug: Calcifediol Oral Product Drug: Cholecalciferol Drug: Paricalcitol Oral Capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : April 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: CTAP101
CTAP101/Calcifediol Capsules 60 mcg once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast
Drug: Calcifediol Oral Capsule
Capsule, daily
Other Name: CTAP101

Experimental: Immediate-release (IR) calcifediol
Immediate-release (IR) calcifediol/266 mcg capsule before breakfast on the mornings of Day 1 and Day 29
Drug: Calcifediol Oral Product
Capsule, once a month

Experimental: Cholecalciferol
Cholecalciferol/Capsules 300,000 IU (high-dose) before breakfast on the mornings of Day 1 and Day 29
Drug: Cholecalciferol
Capsule, once a month

Active Comparator: Paricalcitol
Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and 29 when dosing will occur before breakfast
Drug: Cholecalciferol
Capsule, once a month

Drug: Paricalcitol Oral Capsule
Capsule, daily




Primary Outcome Measures :
  1. Incidence and Severity of Treatment-Emergent Adverse Events as assessed by CTCAE version 5.0 [ Time Frame: 5 months ]
    Detailed information collected for each TEAE will include: AE number, a description of the event, start date, end date or ongoing as of date, outcome, therapy for event



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 18 years of age.
  2. Have stage 3 or 4 CKD (eGFR of ≥15 to <60 mL/min/1.73m2 using the Modification of Diet in Renal Disease equation).
  3. Be without any disease state or physical condition that might impair evaluation of safety and efficacy or which, in the Investigator's opinion, would interfere with study participation, including:

    1. Serum albumin ≤ 3.0 g/dL;
    2. Serum transaminase (alanine transaminase, glutamic pyruvic transaminase, aspartate aminotransferase or glutamic oxaloacetic transaminase) > 2.5 times the upper limit of normal at screening; and,
    3. Urinary albumin excretion ≤3000 μg/mg creatinine.
  4. Exhibit during the initial screening visit:

    1. Plasma iPTH ≥70 pg/mL and <400 pg/mL if receiving calcitriol or other 1α- hydroxylated vitamin D analog (paricalcitol or doxercalciferol); or
    2. Plasma iPTH ≥100 pg/mL and <500 pg/mL if not receiving calcitriol or other 1α- hydroxylated vitamin D analog; and,
    3. Serum total 25-hydroxyvitamin D <30 ng/mL.
  5. If taking calcitriol, other 1α-hydroxylated vitamin D analog, or vitamin D supplementation, must forgo treatment with these non-study agents for the duration of the study and undergo a 4-week washout period.
  6. Exhibit after the 4-week washout period (if required):

    1. Plasma iPTH ≥100 pg/mL and <500 pg/mL;
    2. Corrected serum calcium <9.8 mg/dL; (corrected for serum albumin)
    3. Serum total 25-hydroxyvitamin D <30 ng/mL; and,
    4. Serum phosphorus <5.5 mg/dL.
  7. If taking more than 1,500 mg/day of elemental calcium, reduce calcium use (to approximately 1,000 to ≤1,500 mg/day) for the duration of the study.
  8. Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study.
  9. Female subjects of childbearing potential must be neither pregnant nor lactating and must have negative blood pregnancy tests at the first screening visit.
  10. All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study.
  11. Be able to read, understand and sign the subject Informed Consent Form (ICF) or have a legal authorized representative (LAR) sign the ICF.

Exclusion Criteria:

  1. History of or planned kidney transplant or parathyroidectomy
  2. History (prior 3 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus ≥5.5 mg/dL if not receiving calcitriol or other 1α-hydroxylated vitamin D analog.
  3. Need for phosphate binders to maintain the serum phosphate < 5.5 mg/dL or use of phosphate binders within 4 weeks prior to screening
  4. Use of calcimimetic therapy (cinacalcet or etelcalcetide) within 12 weeks of screening.
  5. Receipt of bisphosphonate therapy or other bone modifying treatment within 6 months prior to enrollment.
  6. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease, intestinal malabsorption disorder, hepatitis or cardiovascular event that in the opinion of the Investigator may worsen or reduce life expectancy, and/or interfere with participation in the study.
  7. History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any reason which, in the opinion of the Investigator makes adherence to a treatment or follow-up schedule unlikely.
  8. Known or suspected hypersensitivity to any of the constituents of the study drugs.
  9. Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening.

Information from the National Library of Medicine

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): NCT03588884


Locations
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United States, California
National Institute of Clinical Research, Inc.
Garden Grove, California, United States, 92844
United States, Illinois
Research by Design, LLC
Chicago, Illinois, United States, 60643
United States, Wisconsin
Spaulding Clinical Research
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
OPKO Health, Inc.
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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT03588884    
Other Study ID Numbers: CTAP101-CL-4001
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Vitamin D Deficiency
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases
Cholecalciferol
Calcifediol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents