Zemplar

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

Treatment

8 FDA approvals

9 Active Studies for Zemplar

What is Zemplar

Paricalcitol

The Generic name of this drug

Treatment Summary

Paricalcitol is a synthetic form of vitamin D. It is used to lower levels of parathyroid hormone in patients with chronic kidney disease. This medication helps to prevent and treat high levels of parathyroid hormone caused by kidney failure.

Zemplar

is the brand name

image of different drug pills on a surface

Zemplar 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 Zemplar Affects Patients

Secondary hyperparathyroidism is caused by a lack of vitamin D in the body, which is usually made naturally in the skin and obtained from diet. Vitamin D needs to go through two processes in the liver and kidney to be activated, and this is done by a hormone called calcitriol. Without enough calcitriol, the parathyroid gland, intestine, kidney, and bone cannot keep calcium and phosphorus in balance. This causes secondary hyperparathyroidism, which affects bone turnover and can cause renal osteodystrophy. Paricalcitol is a medication used to treat secondary hyperparathyroidism and it has been

How Zemplar works in the body

Paricalcitol is a synthetic form of vitamin D. It works by binding to a protein in the body, called the Vitamin D Receptor (VDR). This causes other proteins in the body to work differently, including reducing the amount of Parathyroid Hormone (PTH) in the body. PTH normally increases the amount of calcium in the blood, which can be harmful if it gets too high.

When to interrupt dosage

The recommended measure of Zemplar depends on the diagnosed condition, including Hyperparathyroidism, Secondary, Hemodialysis and Stage 4 Chronic Kidney Disease. The dosage can be found in the table below, contingent upon the technique of administration.

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 Zemplar.

Common Zemplar 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.

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

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

15 active trials are currently evaluating the potential of Zemplar in alleviating 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

Zemplar Reviews: What are patients saying about Zemplar?

5

Patient Review

9/15/2013

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

My PTH level dropped from 245 to 65 after using this treatment, which is amazing.

5

Patient Review

1/9/2014

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

This medication has done wonders for me. I previously had trouble with Vitamin D deficiency and renal issues. Because of the Vitamin D not absorbing, Zemplar has helped that process.

5

Patient Review

3/7/2011

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

I've been using this treatment for over six months and my levels are now normal. It can be tough to find a vitamin supplement without vitamin D, so if you have suggestions please let me know!

5

Patient Review

4/5/2013

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

I feel like this medication is making me more fuzzy-headed, giving me diarrhea, and increasing my depression.

5

Patient Review

5/5/2010

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

I've been taking this medication for over a year now and I haven't seen any changes in my blood tests. Not sure if it's working or not, but it is expensive either way.

4.7

Patient Review

10/25/2009

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

The price is a bit high, but it's worth it for the results.

4.7

Patient Review

7/23/2009

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

4.7

Patient Review

9/20/2009

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

3.7

Patient Review

2/4/2010

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

I'm not entirely sure if I am experiencing an adverse reaction to this medication or not. My doctor prescribed that I take two pills on Tuesday and Friday mornings.

3.3

Patient Review

2/8/2012

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

It does the job it's supposed to, but I sometimes forget when I'm supposed to take it.

3

Patient Review

4/8/2010

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

I'm a little hesitant about this medication because I don't know how it will affect me. I have diabetes and take insulin, so I worry about possible interactions.

3

Patient Review

10/11/2009

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

3

Patient Review

10/23/2009

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

2.3

Patient Review

5/14/2010

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

I unfortunately developed hives when taking this medication on a daily basis.

2

Patient Review

3/11/2012

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

This drug caused a litany of problems for me, from face and hand swelling to lowered blood pressure and excessive snoring. As a dialysis patient, the latter was particularly troublesome. I'm currently in discussions with my doctor to see if we can get me off this medication.

1

Patient Review

3/9/2011

Zemplar for Hyperparathyroidism caused by Chronic Kidney Failure

After taking this medication for a few months, I'm not sure if the side effects are worth it. My legs and ankles swell up, I feel fatigue, my blood pressure gets low, and I get dizzy spells and diarrhea the day after taking the medication.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about zemplar

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

What are the side effects of ZEMPLAR?

"The following are symptoms of the flu: nausea, vomiting, gastrointestinal bleeding, chills, fever, influenza, pneumonia, and severe infection (sepsis)."

Answered by AI

What class of drug is ZEMPLAR?

"The safety and effectiveness of Zemplar have not been established in children younger than 5 years of age (IV dosing) and 10 years of age (orally)."

Answered by AI

What is ZEMPLAR used for?

"ZEMPLAR is a type of vitamin d that is used to prevent and treat secondary hyperparathyroidism. This condition is characterized by an increase in parathyroid hormone levels. ZEMPLAR is approved for use in adults and children who are 10 years of age or older and have Stage 3 or Stage 4 chronic kidney disease, or who are in Stage 5 of renal failure and are receiving dialysis."

Answered by AI

When do you give ZEMPLAR?

"ZEMPLAR should be administered three times per week, no more frequently than every other day, at any time during dialysis. The maintenance dose of ZEMPLAR should be targeted to intact PTH levels within the desired therapeutic range and serum calcium within normal limits."

Answered by AI

Clinical Trials for Zemplar

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 Medicine

AION Healthspan, Inc.

Have you considered Zemplar clinical trials?

We made a collection of clinical trials featuring Zemplar, we think they might fit your search criteria.
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