Sevelamer Hydrochloride

Hyperphosphataemia, Hemodialysis

Treatment

2 FDA approvals

10 Active Studies for Sevelamer Hydrochloride

What is Sevelamer Hydrochloride

Sevelamer

The Generic name of this drug

Treatment Summary

Sevelamer, sold under the brand name Renagel, is a medication used to prevent high levels of phosphorus in people with chronic kidney disease. It works by binding to phosphorus in the intestines and blocking its absorption into the blood.

Renagel

is the brand name

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Sevelamer Hydrochloride Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Renagel

Sevelamer

2006

81

Approved as Treatment by the FDA

Sevelamer, otherwise called Renagel, is approved by the FDA for 2 uses including Hyperphosphataemia and Hemodialysis .

Hyperphosphataemia

Helps manage Hyperphosphataemia

Hemodialysis

Helps manage Hemodialysis Treatment

Effectiveness

How Sevelamer Hydrochloride Affects Patients

People with end-stage renal disease often have too much phosphorus in their blood (called hyperphosphatemia). This can cause a build-up of calcium which can lead to damage. Hyperphosphatemia can also cause an increase in a hormone called parathyroid hormone (PTH) which can cause bone disease. To treat hyperphosphatemia, people reduce the amount of phosphorus they eat, take medicines to prevent their body from absorbing phosphorus, or use dialysis to remove it from their body. Sevelamer is a medicine that can be taken with meals to decrease the amount of phosphorus in the body and also lower

How Sevelamer Hydrochloride works in the body

Sevelamer stops too much phosphate from entering your body by binding to it in the digestive tract. This reduces the amount of phosphate in your blood and lowers your parathyroid hormone levels.

When to interrupt dosage

The recommended dosage of Sevelamer Hydrochloride is contingent upon the determined illness. The amount of dosage deviates, contingent upon the technique of delivery (e.g. Parenteral or Capsule) as noted in the table below.

Condition

Dosage

Administration

Hyperphosphataemia

800.0 mg, , 400.0 mg, 403.0 mg, 1600.0 mg, 2400.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Powder, for suspension, Powder, for suspension - Oral, Parenteral, Tablet, film coated - Parenteral

Hemodialysis

800.0 mg, , 400.0 mg, 403.0 mg, 1600.0 mg, 2400.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Capsule, Capsule - Oral, Powder, for suspension, Powder, for suspension - Oral, Parenteral, Tablet, film coated - Parenteral

Warnings

There are 20 known major drug interactions with Sevelamer Hydrochloride.

Common Sevelamer Hydrochloride Drug Interactions

Drug Name

Risk Level

Description

Mycophenolic acid

Major

The serum concentration of Mycophenolic acid can be decreased when it is combined with Sevelamer.

Raloxifene

Major

Sevelamer can cause a decrease in the absorption of Raloxifene resulting in a reduced serum concentration and potentially a decrease in efficacy.

Technetium Tc-99m oxidronate

Major

Sevelamer may decrease effectiveness of Technetium Tc-99m oxidronate as a diagnostic agent.

(R)-warfarin

Minor

Sevelamer can cause a decrease in the absorption of (R)-warfarin resulting in a reduced serum concentration and potentially a decrease in efficacy.

(S)-Warfarin

Minor

Sevelamer can cause a decrease in the absorption of (S)-Warfarin resulting in a reduced serum concentration and potentially a decrease in efficacy.

Sevelamer Hydrochloride Toxicity & Overdose Risk

Sevelamer has been tested on healthy volunteers up to 14 grams per day over eight days without any side effects. It has also been tested on hemodialysis patients up to 13 grams per day with no reported overdoses. Since sevelamer is not absorbed into the body, it has a low risk of causing toxicity.

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Sevelamer Hydrochloride Novel Uses: Which Conditions Have a Clinical Trial Featuring Sevelamer Hydrochloride?

Condition

Clinical Trials

Trial Phases

Hyperphosphataemia

0 Actively Recruiting

Hemodialysis

13 Actively Recruiting

Not Applicable, Phase 2

Sevelamer Hydrochloride Reviews: What are patients saying about Sevelamer Hydrochloride?

5

Patient Review

7/15/2009

Sevelamer Hydrochloride for High Amount of Phosphate in the Blood

This treatment seems to be effective.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about sevelamer hydrochloride

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

What is the action of sevelamer?

"The drug sevelamer works by binding to phosphate in food as it's being digested, so that the body absorbs less phosphate. This helps to lower blood levels of parathyroid hormone."

Answered by AI

Why do renal patients take sevelamer?

"Sevelamer is an effective medication for decreasing phosphorus and calcium-phosphate levels in the blood, as well as lipid levels, without also raising serum calcium levels. This is true for Chinese dialysis patients whether sevelamer is used as a monotherapy or in combination with other treatments."

Answered by AI

What is sevelamer hydrochloride used for?

"Sevelamer is a prescription medication used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis."

Answered by AI

What drug class is sevelamer hydrochloride?

"Sevelamer is a type of medication known as a phosphate binder. It binds to phosphorus from food in your diet and prevents it from being absorbed into your bloodstream."

Answered by AI

Clinical Trials for Sevelamer Hydrochloride

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Hemodialysis Timing for Kidney Failure

18+
All Sexes
Stanford, CA

The goal of this clinical trial is to evaluate the feasibility of two different preoperative hemodialysis schedules for people with end-stage kidney disease (ESKD) who undergo surgical procedures. The main questions it aims to answer are: Is it feasible to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis? Is it safe to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis? Researchers will compare the two hemodialysis schedules to see if the scheduling and safety profiles are the same. Participants will: Answer questions about their health up to 4 weeks before and 4 weeks after the surgical procedure. Receive hemodialysis on the day of the surgical procedure or not, depending on the study treatment assignment.

Waitlist Available
Has No Placebo

Stanford University

Vikram Fielding-Singh, MD, JD

Image of London Health Sciences Centre in London, Canada.

Wearable Ultrafiltration Device for Kidney Failure

18+
All Sexes
London, Canada

Kidney failure is common. In some people the ability of the kidneys to clean poisons out of the blood gets so low they need to be hooked up to a machine three times a week to do it for them. This is called dialysis. Unfortunately, although this treatment removes those waste products, people who need dialysis die much more often than people who don't need dialysis. Dialysis causes extreme stress on the body and leads to many organs being damaged. Removing fluid from the body quickly causes the equivalent of repeated little heart attacks or little strokes in the brain. Many patients struggle to tolerate having all the fluid that they have drunk since their last dialysis session removed- without unpleasant symptoms of dangerously low blood pressure (which makes the damage worse). Dialysis treatments can be done more slowly or more often, but that means having to spend a lot more time at the hospital and is difficult for the health system to be able to provide the extra treatment time. Could extra fluid be removed in between dialysis sessions? Up to now there has not been a way to effectively do this. Investigators have now designed and built an entirely new, very small and very simplified, device that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for conventional dialysis sessions, but it can provide additional and gentle removal of fluid which wasn't able to be taken off during a standard treatment session. If this study is successful, it will be the first time that a wearable device has been successfully built and used to take off extra fluid when dialysis patients are not in the hospital. The ability to do this opens up the possibility of, 1) helping to treat patients (both making people feel better and live longer) who can't tolerate getting off all the fluid in the short 3-4 hours they are on the dialysis machine in the hospital, and 2) helping patients who feel OK having the fluid taken off but are silently being subjected to damage to their organs due to the rapid removal, have reduced damage.

Waitlist Available
Has No Placebo

London Health Sciences Centre

Dr. Christopher McIntyre, MBBS DM

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"Move More" Exercise Program for Hemodialysis Patients

18+
All Sexes
Tucson, AZ

The goal of this clinical trial is to compare the efficacy of a standard intradialytic exercise program (control group) to an individualized, patient-centered, "Move-More" physical activity intervention (intervention group) in hemodialysis (HD) patients. Exercise programs often fail to yield robust benefits for many HD patients, in part because the type and volume of exercise prescribed is inappropriate for a variety of reasons, and the benefits from these studies are often disappointing, as they are characterized by poor adherence, high dropout rates, and modest effects on physical function, body composition, cardiovascular disease risk, and other outcomes related to quality of life (QOL). To address this, the investigators have designed a novel physical activity intervention "Move More" that is designed to overcome many of the barriers to increasing physical activity in this population. This study aims to compare the efficacy of a standard intradialytic exercise program (control group) to an individualized, patient-centered, "Move-More" physical activity intervention (intervention group) in HD patients. The investigators primary hypothesis is that patients randomized to the Move More intervention will increase their physical activity levels more than those in the intradialytic exercise group. The main question it aims to answer is: • Does "Move More" increase the physical activity levels (minutes) measured through weekly minutes of physical activity and the LoPAQ questionnaire more than those in the standard intradialytic exercise program? For secondary outcomes this study aims to answer the following: * Does "Move More" improve the physical function of hemodialysis patients assessed by the short physical performance battery (SPBB) more than those in the standard intradialytic exercise program? * Does "Move More" decrease fatigue assess by the SONG-HD survey more than those in the standard intradialytic exercise program? * Does "Move More" decrease symptoms of depression assessed by PROMIS Depression Short Form 8a more than those in the standard intradialytic exercise program? * Does "Move More" increase the amount of exercise measured through a point system more than those in the standard intradialytic exercise program? * Does "Move More" improve blood pressure (BP) more than those in the standard intradialytic exercise program?

Recruiting
Has No Placebo

DCI Desert Dialysis

Kenneth R Wilud, PhD

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InnAVasc Graft Implant for Kidney Failure

18 - 90
All Sexes
Lexington, KY

The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.

Recruiting
Has No Placebo

Fayette Surgical Associates (+24 Sites)

John Ross, MD

InnAVasc Medical, Inc.

Image of London Health Sciences Centre in London, Canada.

Higher vs. Lower Hemodialysate Magnesium for Kidney Failure

18+
All Sexes
London, Canada

Many patients on hemodialysis have low levels of magnesium. Magnesium is needed to keep the heart, kidneys, and other organs working properly. Patients with low serum magnesium concentration have a higher risk of death, heart issues, muscle cramps and fractures. There are several reasons why patients on dialysis have low levels of magnesium-these include poor diet, medication interference, and the dialysis procedure itself, which leaches small amounts of magnesium from the blood during each treatment. One way to make sure that patients on dialysis are getting enough magnesium is to increase its concentration in the dialysate. The investigator would like to do a randomized controlled trial to determine the effect of increasing the concentration of magnesium in the dialysate on the risk of people on dialysis dying or being admitted to the hospital due to heart issues. The investigator thinks increasing the magnesium in the dialysate will help patients live longer, have fewer hospitalisations related to heart disease and patients may also experience less cramping associated with dialysis. This simple adjustment to the dialysis procedure can be done at little cost and may even reduce overall healthcare costs. If the investigator can show that increasing magnesium in the dialysate improves patients' health, then it could become the standard of care for all patients on dialysis.

Waitlist Available
Has No Placebo

London Health Sciences Centre

Amit X Garg, PhD, MD

ICES

Have you considered Sevelamer Hydrochloride clinical trials?

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