Rayaldee

Hyperparathyroidism, Secondary, Vitamin D Deficiency (10 ng/mL to 30 ng/mL), Renal Insufficiency, Chronic + 1 more

Treatment

6 FDA approvals

9 Active Studies for Rayaldee

What is Rayaldee

Calcifediol

The Generic name of this drug

Treatment Summary

Calcifediol is a metabolite of vitamin D3 that is produced in the liver and is used to measure the amount of vitamin D in a person's body. It is used to treat conditions like rickets and osteomalacia and helps to mineralize bones.

Rayaldee

is the brand name

image of different drug pills on a surface

Rayaldee Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Rayaldee

Calcifediol

2016

1

Approved as Treatment by the FDA

Calcifediol, also known as Rayaldee, is approved by the FDA for 6 uses including Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease, Stage 3 (Moderate) .

Secondary Hyperparathyroidism (SHPT)

Chronic Kidney Disease, Stage 3 (Moderate)

Hyperparathyroidism, Secondary

Vitamin D Deficiency (10 ng/mL to 30 ng/mL)

Renal Insufficiency, Chronic

Stage 4 Chronic Kidney Disease

Effectiveness

How Rayaldee Affects Patients

Calcidiol is a precursor of vitamin D3, which is a hormone that helps the body regulate calcium and phosphorus levels, and helps with the absorption of vitamin A. Not getting enough vitamin D can lead to two diseases: rickets in children, which causes bone deformities, and osteomalacia in adults. Causes of vitamin D deficiency can include not getting enough sunlight, not getting enough from your diet, and some genetic defects. Vitamin D helps the body keep calcium balanced and control the parathyroid hormone. It also helps the body absorb calcium and phosphorus, and move them from bones to the bloodstream.

How Rayaldee works in the body

Calcidiol is a precursor to the active form of vitamin D, called calcitriol. When calcitriol enters the cell, it binds to receptors which then act as a switch to turn on or off certain genes. This gene switch helps to increase calcium absorption from the gut and kidneys, helping to raise levels of calcium in the bloodstream. Calcitriol also binds to receptors in the intestine, which helps to absorb more calcium from the food we eat.

When to interrupt dosage

The quantity of Rayaldee is dependent upon the diagnosed disorder, including Chronic Kidney Disease, Stage 3 (Moderate), Stage 4 Chronic Kidney Disease and Hyperparathyroidism, Secondary. The dosage varies, contingent upon the procedure of delivery (e.g. Capsule - Oral or Oral) featured in the table beneath.

Condition

Dosage

Administration

Hyperparathyroidism, Secondary

, 0.03 mg, 0.02 mg

Oral, Capsule, extended release, , Capsule, extended release - Oral, Capsule, Capsule - Oral

Vitamin D Deficiency (10 ng/mL to 30 ng/mL)

, 0.03 mg, 0.02 mg

Oral, Capsule, extended release, , Capsule, extended release - Oral, Capsule, Capsule - Oral

Renal Insufficiency, Chronic

, 0.03 mg, 0.02 mg

Oral, Capsule, extended release, , Capsule, extended release - Oral, Capsule, Capsule - Oral

Stage 4 Chronic Kidney Disease

, 0.03 mg, 0.02 mg

Oral, Capsule, extended release, , Capsule, extended release - Oral, Capsule, Capsule - Oral

Warnings

There are 20 known major drug interactions with Rayaldee.

Common Rayaldee Drug Interactions

Drug Name

Risk Level

Description

Sucralfate

Major

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

1alpha,24S-Dihydroxyvitamin D2

Moderate

The risk or severity of adverse effects can be increased when Calcifediol is combined with 1alpha,24S-Dihydroxyvitamin D2.

1alpha-Hydroxyvitamin D5

Moderate

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

Acetyldigitoxin

Moderate

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

Acetyldigoxin

Moderate

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

Rayaldee Toxicity & Overdose Risk

Overdosing on cefazolin may cause bone pain, constipation, diarrhea, drowsiness, dry mouth, headaches, increased thirst, frequent urination (especially at night), irregular heartbeat, itchy skin, loss of appetite, a metallic taste in the mouth, muscle pain, nausea or vomiting (especially in children or adolescents), and fatigue.

image of a doctor in a lab doing drug, clinical research

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

Currently, there are 10 active studies evaluating the potential of Rayaldee to ameliorate Chronic Kidney Disease Stage 3 (Moderate), Secondary Hyperparathyroidism and Vitamin D Deficiency (10 ng/mL to 30 ng/mL).

Condition

Clinical Trials

Trial Phases

Hyperparathyroidism, Secondary

3 Actively Recruiting

Phase 3, Phase 2

Renal Insufficiency, Chronic

2 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Vitamin D Deficiency (10 ng/mL to 30 ng/mL)

0 Actively Recruiting

Stage 4 Chronic Kidney Disease

5 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Rayaldee Reviews: What are patients saying about Rayaldee?

5

Patient Review

10/27/2018

Rayaldee for Hyperparathyroidism caused by Chronic Kidney Failure

I have chronic kidney disease and parathyroid hormone. My vitamin D was extremely low, but after taking this medication for the past six months, it is now normal. My co-pay is $75.00 per month, which isn't too bad considering the cost without insurance would be around one thousand dollars.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about rayaldee

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

Is Rayaldee vitamin D?

"RAYALDEE is a treatment for hyperparathyroidism that comes as a result of chronic kidney disease. It is for stage 3 or 4 adult patients who have a serum total 25-hydroxyvitamin D level that is less than 30 ng/mL."

Answered by AI

What is Rayaldee used for?

"Rayaldee is an extended-release capsule taken by mouth that is prescribed to treat adults with secondary hyperparathyroidism, stage 3 or 4 chronic kidney disease, and low vitamin d levels."

Answered by AI

Is there a generic for Rayaldee?

"Currently, there is no drug in the United States that is the same as Rayaldee. However, there are fake versions of Rayaldee being sold online by unlicensed pharmacies. These drugs may not be safe, as they are not regulated."

Answered by AI

Who manufactures Rayaldee?

"OPKO, a company based in Miami, announced today that the FDA has approved their drug Rayaldee for chronic kidney disease. This approval comes only three months after OPKO received a complete response letter from the FDA, due to concerns that the FDA had about the plant where the drug was being produced."

Answered by AI

Clinical Trials for Rayaldee

Image of Perelman Center for Advanced Medicine in Philadelphia, United States.

Exercise Program for Kidney Transplant Candidates

18+
All Sexes
Philadelphia, PA

The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants. The main questions it aims to answer are: * Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list? * Do participants follow the exercise program and wear a physical activity tracker as asked? * Is the program safe and well tolerated? Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function: * Usual pre-transplant care with a physical activity tracker * Usual pre-transplant care plus an online exercise program Participants will: * Wear a wrist activity tracker to measure daily physical activity * Complete a one-week baseline period before being assigned to a study group * Be randomly assigned (like flipping a coin) to one of two groups * If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback * Answer questionnaires about their health, activity, and experience in the study This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.

Recruiting
Has No Placebo

Perelman Center for Advanced Medicine

Sarah Schrauben, MD, MSCE

Have you considered Rayaldee clinical trials?

We made a collection of clinical trials featuring Rayaldee, we think they might fit your search criteria.
Go to Trials
Image of Ohio State University Comprehensive Cancer Center in Columbus, United States.

Peptide Vaccine for Cancer Prevention

18 - 65
All Sexes
Columbus, OH

This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause in patients awaiting solid organ transplants.

Phase 1
Recruiting

Ohio State University Comprehensive Cancer Center

Timothy J Voorhees, MD

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 (+1 Sites)

AION Healthspan, Inc.