Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency

NCT03588884 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CTAP101-CL-4001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

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

Conditions

Secondary Hyperparathyroidism Due to Renal Causes; Vitamin D Insufficiency; CKD Stage 3; CKD Stage 4

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  This study is descriptive and no primary or secondary efficacy endpoints are defined.

  5 months

Study Arms (4)

CTAP101

ACTIVE COMPARATOR

CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast

Drug: Calcifediol Oral Capsule

Immediate-release (IR) calcifediol

EXPERIMENTAL

Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29

Drug: Calcifediol Oral Product

Cholecalciferol

EXPERIMENTAL

Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29

Drug: Cholecalciferol

Paricalcitol

ACTIVE COMPARATOR

Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast

Drug: Cholecalciferol; Drug: Paricalcitol Oral Capsule

Interventions

Calcifediol Oral Capsule DRUG

Capsule, daily

Also known as: CTAP101

CTAP101

Calcifediol Oral Product DRUG

Capsule, once a month

Immediate-release (IR) calcifediol

Cholecalciferol DRUG

Capsule, once a month

Cholecalciferol; Paricalcitol

Paricalcitol Oral Capsule DRUG

Capsule, daily

Paricalcitol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age.
• Have stage 3 or 4 CKD (estimated glomerular filtration rate \[eGFR\] of ≥15 to \<60 millilter per minute per 1.73 meter square (mL/min/1.73 m2) using the Modification of Diet in Renal Disease equation).
• 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:
• Serum albumin ≤ 3.0 (grams per deciliter (g/dL);
• Serum transaminase (alanine transaminase, glutamic pyruvic transaminase, aspartate aminotransferase or glutamic oxaloacetic transaminase) \> 2.5 times the upper limit of normal at screening; and,
• Urinary albumin excretion ≤3000 microgram per milligram (μg/mg) creatinine.
• Exhibit during the initial screening visit:
• Plasma intact parathyroid hormone (iPTH) ≥70 picogram per milliliter (pg/mL) and \<400 pg/mL if receiving calcitriol or other 1α- hydroxylated vitamin D analog (paricalcitol or doxercalciferol); or
• Plasma iPTH ≥100 pg/mL and \<500 pg/mL if not receiving calcitriol or other 1α- hydroxylated vitamin D analog; and,
• Serum total 25-hydroxyvitamin D \<30 nanogram per milliliter (ng/mL).
• 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.
• Exhibit after the 4-week washout period (if required):
• Plasma iPTH ≥100 pg/mL and \<500 pg/mL;
• Corrected serum calcium \<9.8 mg/dL; (corrected for serum albumin)
• Serum total 25-hydroxyvitamin D \<30 nanogram per milliliter (ng/mL); and,

You may not qualify if:

• History of or planned kidney transplant or parathyroidectomy
• 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.
• Need for phosphate binders to maintain the serum phosphate \< 5.5 mg/dL or use of phosphate binders within 4 weeks prior to screening
• Use of calcimimetic therapy (cinacalcet or etelcalcetide) within 12 weeks of screening.
• Receipt of bisphosphonate therapy or other bone modifying treatment within 6 months prior to enrollment.
• 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.
• 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.
• Known or suspected hypersensitivity to any of the constituents of the study drugs.
• Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening.

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (3)

National Institute of Clinical Research, Inc.

Garden Grove, California, 92844, United States

Location

Research by Design, LLC

Chicago, Illinois, 60643, United States

Location

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

Calcifediol; Cholecalciferol; paricalcitol

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: OPKO Health Inc
• Organization: OPKO Health Inc

contact@opko.com

3055754100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 17, 2018
• Study Start: June 8, 2018
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: December 9, 2022
• Results First Posted: December 9, 2022

Record last verified: 2022-11

Locations

US (3)