Paricalcitol

Hyperparathyroidism, Secondary, Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic + 1 more

Treatment

8 FDA approvals

9 Active Studies for Paricalcitol

What is Paricalcitol

Paricalcitol

The Generic name of this drug

Treatment Summary

Paricalcitol is a type of synthetic vitamin D that helps lower parathyroid hormone levels. It is used to prevent and treat high levels of parathyroid hormone in people with chronic kidney disease.

Zemplar

is the brand name

Paricalcitol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Zemplar

Paricalcitol

1998

84

Approved as Treatment by the FDA

Paricalcitol, also known as Zemplar, is approved by the FDA for 8 uses which include Hyperparathyroidism, Secondary and Hyperparathyroidism, Secondary .

Hyperparathyroidism, Secondary

Hyperparathyroidism, Secondary

Renal Insufficiency, Chronic

Chronic Kidney Disease, Stage 3 (Moderate)

Secondary Hyperparathyroidism (SHPT)

Stage 4 Chronic Kidney Disease

Stage 5 Chronic Kidney Disease (CKD)

prophylaxis of secondary hyperparathyroidism

Effectiveness

How Paricalcitol Affects Patients

Secondary hyperparathyroidism is a condition in which the body has too much of the hormone parathyroid hormone (PTH) due to inadequate levels of active vitamin D. Vitamin D helps form and maintain normal bones and is created in the skin and from food. Vitamin D needs to be changed in the liver and kidneys before it works properly. When the kidneys are not healthy, the activation of vitamin D is lowered, causing PTH to rise. This leads to problems with calcium and phosphorus levels in the body and can cause renal osteodystrophy (loss of bone mass). Paricalcitol is a drug that helps regulate P

How Paricalcitol works in the body

Paricalcitol is a man-made version of vitamin D that works to reduce parathyroid hormone levels. It does this by binding to the vitamin D receptor and activating pathways that respond to vitamin D. This helps stop the body from making too much parathyroid hormone.

When to interrupt dosage

The suggested dosage of Paricalcitol is contingent upon the determined disorder, including Hyperparathyroidism, Secondary, Hemodialysis and Stage 4 Chronic Kidney Disease. The measure of dosage differs as outlined by the technique of delivery outlined in the table below.

Condition

Dosage

Administration

Hyperparathyroidism, Secondary

, 0.005 mg/mL, 0.002 mg/mL, 0.001 mg, 0.002 mg, 0.004 mg, 1.0 mg, 2.0 mg, 4.0 mg, 0.01 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous, Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule, Capsule - Oral, Solution, Solution - Intravenous

Renal Insufficiency, Chronic

, 0.005 mg/mL, 0.002 mg/mL, 0.001 mg, 0.002 mg, 0.004 mg, 1.0 mg, 2.0 mg, 4.0 mg, 0.01 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous, Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule, Capsule - Oral, Solution, Solution - Intravenous

Hyperparathyroidism, Secondary

, 0.005 mg/mL, 0.002 mg/mL, 0.001 mg, 0.002 mg, 0.004 mg, 1.0 mg, 2.0 mg, 4.0 mg, 0.01 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous, Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule, Capsule - Oral, Solution, Solution - Intravenous

Stage 4 Chronic Kidney Disease

, 0.005 mg/mL, 0.002 mg/mL, 0.001 mg, 0.002 mg, 0.004 mg, 1.0 mg, 2.0 mg, 4.0 mg, 0.01 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Injection, Injection - Intravenous, Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule, Capsule - Oral, Solution, Solution - Intravenous

Warnings

There are 20 known major drug interactions with Paricalcitol.

Common Paricalcitol Drug Interactions

Drug Name

Risk Level

Description

Sucralfate

Major

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

1alpha,24S-Dihydroxyvitamin D2

Moderate

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

1alpha-Hydroxyvitamin D5

Moderate

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

Acetyldigitoxin

Moderate

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

Acetyldigoxin

Moderate

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

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

Fifteen clinical trials are assessing the potential of Paricalcitol to control Stage 4 Chronic Kidney Disease, Chronic Kidney Disease Stage 3 (Moderate) and Hemodialysis.

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

Hyperparathyroidism, Secondary

0 Actively Recruiting

Stage 4 Chronic Kidney Disease

6 Actively Recruiting

Phase 4, Phase 1, Phase 2, Not Applicable

Paricalcitol Reviews: What are patients saying about Paricalcitol?

4.7

Patient Review

9/1/2008

Paricalcitol for Hyperparathyroidism caused by Chronic Kidney Failure

3.3

Patient Review

3/26/2010

Paricalcitol for Hyperparathyroidism caused by Chronic Kidney Failure

3

Patient Review

6/27/2011

Paricalcitol for Hyperparathyroidism caused by Chronic Kidney Failure

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Patient Q&A Section about paricalcitol

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

Is paricalcitol a steroid?

"It is a seco-cholestane and a hydroxy seco-steroid derivative.

Paricalcitol is a seco-cholestane and a hydroxy seco-steroid. It acts as an antiparathyroid drug. It is a seco-cholestane and a hydroxy seco-steroid derivative."

Answered by AI

What is another name for paricalcitol?

"Zemplar (paricalcitol) Injection is a form of vitamin d that is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5."

Answered by AI

Is paricalcitol a vitamin D?

"A synthetic form of vitamin D2 called paricalcitol was created to treat secondary hyperthyroidism connected to chronic renal failure."

Answered by AI

What is paricalcitol prescribed for?

"Paricalcitol is used to treat and prevent hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition caused by the parathyroid glands located in the neck making too much parathyroid hormone (PTH)."

Answered by AI

Clinical Trials for Paricalcitol

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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

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 Medicine

AION Healthspan, Inc.

Have you considered Paricalcitol clinical trials?

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Go to Trials
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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