Rayaldee

Hyperparathyroidism, Secondary, Vitamin D Deficiency (10 ng/mL to 30 ng/mL), Renal Insufficiency, Chronic + 1 more
Treatment
6 FDA approvals
10 Active Studies for Rayaldee

What is Rayaldee

CalcifediolThe Generic name of this drug
Treatment SummaryCalcifediol 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.
Rayaldeeis 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 PatientsCalcidiol 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 bodyCalcidiol 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 - Oral, Capsule
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 - Oral, Capsule
Renal Insufficiency, Chronic
, 0.03 mg, 0.02 mg
Oral, Capsule, extended release, , Capsule, extended release - Oral, Capsule - Oral, Capsule
Stage 4 Chronic Kidney Disease
, 0.03 mg, 0.02 mg
Oral, Capsule, extended release, , Capsule, extended release - Oral, Capsule - Oral, Capsule

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 RiskOverdosing 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.
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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
2 Actively Recruiting
Phase 3, Not Applicable
Renal Insufficiency, Chronic
3 Actively Recruiting
Phase 2, Phase 1, Not Applicable
Vitamin D Deficiency (10 ng/mL to 30 ng/mL)
0 Actively Recruiting
Stage 4 Chronic Kidney Disease
6 Actively Recruiting
Phase 4, Phase 1, Phase 2, Not Applicable

Rayaldee Reviews: What are patients saying about Rayaldee?

5Patient 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.
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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 Dartmouth Hitchcock Medical Center in Lebanon, United States.

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
Image of Dartmouth Hitchcock Medical Center in Lebanon, United States.

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 MedicineAION Healthspan, Inc.
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Image of University of Rochester Medical Center in Rochester, United States.

Sulforaphane for Chronic Kidney Disease

18 - 80
All Sexes
Rochester, NY
The Sulforaphane Production System® in Avmacol Extra Strength (ES) supplies broccoli seed extract (glucoraphanin) and Myrosimax® (Active Myrosinase Enzyme) which helps promote sulforaphane production in your body. The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in Chronic Kidney Disease (CKD) patients. They will test this hypothesis in a randomized, double-blind, placebo controlled Phase 2 clinical trial. This proposed study has been funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), R01 DK128677.
Phase 2
Waitlist Available
University of Rochester Medical CenterNutramax Laboratories, Inc.
Image of UCI in Orange, United States.

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
Image of McGill University Health Center Research Institute in Montreal, Canada.

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
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