Hectorol

Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Stage 4 Chronic Kidney Disease

Treatment

9 Active Studies for Hectorol

What is Hectorol

Doxercalciferol

The Generic name of this drug

Treatment Summary

Doxercalciferol is a form of vitamin D2 that is activated in the body to become 1α,25-(OH)2D2, a form of vitamin D that occurs naturally. It is used to treat an overactive parathyroid gland in patients with chronic kidney disease on dialysis, as well as Stage 3 and 4 chronic kidney disease. It is sold under the brand name Hectoral and is made by Genzyme Corporation and Catalent Pharma Solutions, Inc.

Hectorol

is the brand name

image of different drug pills on a surface

Hectorol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Hectorol

Doxercalciferol

2006

47

Effectiveness

How Hectorol works in the body

Calcitriol and 1α,25-(OH)2D2 help regulate the amount of calcium in the blood, to support normal body functions. They control how much calcium is absorbed from food and how much is reabsorbed by the kidneys, as well as how much calcium is released from the bones. These vitamin D metabolites work by attaching to special receptor proteins in different parts of the body. People with chronic kidney disease can't produce enough of these metabolites, which leads to an excess of parathyroid hormone and causes metabolic bone disease.

When to interrupt dosage

The measure of Hectorol is contingent upon the diagnosed affliction, including Chronic Kidney Disease, Stage 3 (Moderate), Hemodialysis and Stage 4 Chronic Kidney Disease. The amount likewise varies as per the process of delivery featured in the table beneath.

Condition

Dosage

Administration

Stage 4 Chronic Kidney Disease

0.002 mg/mL, , 0.0005 mg, 0.0025 mg, 0.001 mg, 0.004 mg/mL

, Intravenous, Injection, Injection - Intravenous, Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Capsule, Capsule - Oral, Injection, solution, Injection, solution - Intravenous

Hyperparathyroidism, Secondary

0.002 mg/mL, , 0.0005 mg, 0.0025 mg, 0.001 mg, 0.004 mg/mL

, Intravenous, Injection, Injection - Intravenous, Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Capsule, Capsule - Oral, Injection, solution, Injection, solution - Intravenous

Renal Insufficiency, Chronic

0.002 mg/mL, , 0.0005 mg, 0.0025 mg, 0.001 mg, 0.004 mg/mL

, Intravenous, Injection, Injection - Intravenous, Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Capsule, Capsule - Oral, Injection, solution, Injection, solution - Intravenous

Warnings

Hectorol Contraindications

Condition

Risk Level

Notes

Hypercalcemia

Do Not Combine

vitamin D intoxication

Do Not Combine

There are 20 known major drug interactions with Hectorol.

Common Hectorol Drug Interactions

Drug Name

Risk Level

Description

Sucralfate

Major

The serum concentration of Sucralfate can be increased when it is combined with Doxercalciferol.

1alpha-Hydroxyvitamin D5

Moderate

The risk or severity of adverse effects can be increased when Doxercalciferol is combined with 1alpha-Hydroxyvitamin D5.

Acetyldigitoxin

Moderate

The risk or severity of ventricular arrhythmias and Cardiac Arrhythmia can be increased when Doxercalciferol is combined with Acetyldigitoxin.

Acetyldigoxin

Moderate

The risk or severity of ventricular arrhythmias and Cardiac Arrhythmia can be increased when Doxercalciferol is combined with Acetyldigoxin.

Aluminum hydroxide

Moderate

The serum concentration of Aluminum hydroxide can be increased when it is combined with Doxercalciferol.

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Hectorol Novel Uses: Which Conditions Have a Clinical Trial Featuring Hectorol?

Fifteen active studies are currently in progress to assess the potential of Hectorol to mitigate the effects of Hemodialysis, Hyperparathyroidism, Secondary and Stage 4 Chronic Kidney Disease.

Condition

Clinical Trials

Trial Phases

Renal Insufficiency, Chronic

3 Actively Recruiting

Phase 2, Phase 1, Not Applicable

Hyperparathyroidism, Secondary

2 Actively Recruiting

Phase 3, Not Applicable

Stage 4 Chronic Kidney Disease

6 Actively Recruiting

Phase 4, Phase 1, Phase 2, Not Applicable

Hectorol Reviews: What are patients saying about Hectorol?

5

Patient Review

4/10/2010

Hectorol for Hyperparathyroidism caused by Chronic Kidney Failure

I feel better taking this medication. It is small and easy to swallow, which is great for me since I have polycystic kidneys and they aren't working very well (only at seven percent). The downside is that it's quite expensive.

5

Patient Review

3/30/2009

Hectorol for Hyperparathyroidism caused by Chronic Kidney Failure

Hectorol was easy to take and affordable, and it did its job well. I'm now doing great thanks to my new kidney, and so my doctors have taken me off the medication.

4.7

Patient Review

9/23/2007

Hectorol for Hyperparathyroidism caused by Chronic Kidney Failure

3

Patient Review

4/21/2010

Hectorol for Hyperparathyroidism caused by Chronic Kidney Failure

Didn't see any significant results.

2.3

Patient Review

10/19/2009

Hectorol for Hyperparathyroidism caused by Chronic Kidney Failure

I found that this drug caused me to feel dizzy.

1

Patient Review

5/14/2010

Hectorol for Hyperparathyroidism caused by Chronic Kidney Failure

I took one caplet and felt very sick afterwards. I would not recommend this medication.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about hectorol

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Hectorol used for?

"Hectorol is a prescription vitamin d hormone that is a treatment for SHPT in adult patients with CKD."

Answered by AI

Does Hectorol raise calcium?

"PTH stands for parathyroid hormone. This medication works by decreasing PTH levels and increasing calcium and phosphorus levels in the body."

Answered by AI

Why is Hectorol given on dialysis?

"The active ingredient in this medicine works by decreasing the amount of PTH made by your parathyroid glands.

This medication is used to treat people who have serious kidney disease and are on dialysis. These people have high levels of a substance called parathyroid hormone (PTH). PTH levels affect the balance of minerals in your body, such as calcium and phosphorus. This can cause weak bones. The active ingredient in this medicine decreases the amount of PTH made by your parathyroid glands."

Answered by AI

Is Hectorol active vitamin D?

"The chemical structure of doxercalciferol is similar to that of vitamin D2.

Doxercalciferol is a synthetic form of vitamin D2 that is biologically active. It is structurally similar to vitamin D2."

Answered by AI

Clinical Trials for Hectorol

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Agenda-Setting Tool for Chronic Kidney Disease

18+
All Sexes
Lebanon, NH

The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial. The intervention the researchers plan to use is Chronic Kidney Disease (CKD) Topics, and it is a structured clinical agenda-setting intervention (SAS), or a customized list of discussion topics. The people the researchers are practicing using the SAS with have advanced CKD (stages 4-5), and many of them live in rural areas. The researchers will practice administering CKD Topics, along with survey questions. By doing the open pilot, the researchers will learn if they need to modify the steps they plan to take in the larger trial. The main questions the researchers aim to answer are: * Do the steps for identifying eligible participants work? * Do the steps for administering CKD Topics work? * Do the steps to administer survey questions work?

Waitlist Available
Has No Placebo

Dartmouth Hitchcock Medical Center

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Structured Agenda-Setting Tool for Chronic Kidney Disease

18+
All Sexes
Lebanon, NH

The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. The researchers will compare the SAS intervention to usual care (the way clinicians usually practice) to see how well it works for people with advanced CKD. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time. The researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants. The main questions the researchers aim to answer are: * Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility * Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy

Waitlist Available
Has No Placebo

Dartmouth Hitchcock Medical Center

Image of University of Miami, Leonard M. Miller School of Medicine in Miami, United States.

AION-301 for Chronic Kidney Disease

35 - 75
All Sexes
Miami, FL

The goal of this clinical trial is to learn about the safety (good or bad) of giving two AION-301 intravenous (IV) infusions, in adults with Stage 3 Chronic Kidney Disease (CKD). It will also help to learn if AION-301 reduces the symptoms of CKD and/or progression. The main questions it aims to answer are: * Do participants have medical problems (adverse events) after receiving two infusions of AION-301? * Do participants feel better (have reduced and/or delayed CKD symptoms)? * To learn about how AION-301 works in participants with CKD? Researchers will compare AION-301 to a placebo (a look-alike substance that contains no drug) to see if AION-301 works to treat Stage 3 CKD. Participants will: * Receive two infusions of AION-301 or placebo on two separate days (Day 0 and Day 4). * Receive oral vitamins at the clinic and to take at home for 90 days. * Visit the clinic for a minimum of 9 times, over 6 months for checkups and tests, but could be up to 12 times, over 24 months for checkups and tests.

Phase 1 & 2
Recruiting

University of Miami, Leonard M. Miller School of Medicine

AION Healthspan, Inc.

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Plant-Focused Diet for Diabetes and Chronic Kidney Disease

18+
All Sexes
Orange, CA

In this pilot clinical trial, the investigators will recruit and randomize 120 patients with diabetes mellitus and chronic kidney disease (CKD/DM) stages 3 to 5 to a patient-centered and flexible Plant-Focused Nutrition in Diabetes (PLAFOND) diet with \>2/3 plant-based sources, which will be compared with a standard-of-care CKD diet, which is usually a low-potassium and low-salt diet, over a 6-month period. Through this study, the investigators will determine whether the plant-focused diet intervention is feasible for patient adherence, whether this diet is safe by avoiding malnutrition, frailty, and high potassium or glucose blood levels, and whether patient reported outcomes are favorably impacted.

Waitlist Available
Has No Placebo

UCI (+1 Sites)

Kamyar Kalantar-Zadeh, MD, MPH, PhD

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Canagliflozin for Chronic Kidney Disease

18+
All Sexes
Montreal, Canada

The study objective is to characterize the pharmacokinetics (PK), pharmacodynamics, and surrogate measures of efficacy for canagliflozin in patients with advanced CKD, including those receiving HD. As the CV and renoprotective effects of SGLT-2 inhibitors appear to be independent of glycemic control, the investigators hypothesize that canagliflozin will reduce albuminuria in patients with advanced CKD in the same manner as observed in patients with higher eGFR. The investigators also hypothesize that the 300 mg dose will be equally safe as the 100 mg dose but will have greater efficacy, given data which suggests efficacy correlates with drug exposure in patients without CKD. Given its negligible renal elimination, the investigators hypothesize that exposure to canagliflozin 100 mg at steady state will not exceed the standard bioequivalence boundary of 80-125% in patients receiving HD, compared with published estimates with the 300 mg dose at steady state in individuals with preserved kidney function.

Phase 4
Recruiting

McGill University Health Center Research Institute (+1 Sites)

Thomas Mavrakanas, MD