Sevelamer Carbonate

Hyperphosphataemia, Hemodialysis

Treatment

2 FDA approvals

11 Active Studies for Sevelamer Carbonate

What is Sevelamer Carbonate

Sevelamer

The Generic name of this drug

Treatment Summary

Sevelamer is a medication prescribed to help prevent high levels of phosphate in the blood for individuals with chronic kidney disease. It is manufactured by Genzyme and sold under the brand name Renagel.

Renagel

is the brand name

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Sevelamer Carbonate 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 Carbonate Affects Patients

People with end-stage renal disease often have too much phosphorus in their blood, which can cause calcium to settle in different parts of the body (ectopic calcification). This can also raise levels of a hormone called PTH, which can lead to a bone disease called osteitis fibrosa. To lower phosphorus levels, people can reduce the amount of phosphorus they eat, take a medicine called sevelamer, or use dialysis. Sevelamer taken during meals has been found to lower phosphorus levels and also lower cholesterol levels. It works similarly as a capsule or tablet.

How Sevelamer Carbonate works in the body

Sevelamer prevents too much phosphate from entering the bloodstream. It does this by binding to phosphate in the gut and stopping it from being absorbed. This reduces the amount of phosphate in the blood, helping to control levels of parathyroid hormone.

When to interrupt dosage

The suggested dosage of Sevelamer Carbonate is contingent upon the determined condition. The measure of dosage fluctuates, according to the technique of delivery (e.g. Parenteral or Capsule) featured in the following table.

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 Carbonate.

Common Sevelamer Carbonate 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 Carbonate Toxicity & Overdose Risk

Sevelamer has been tested on healthy volunteers in doses up to 14 grams per day for eight days and no adverse side effects were reported. Patients receiving hemodialysis have been given up to 13 grams per day with no reported overdoses. Since sevelamer is not absorbed, it is unlikely to cause any systemic toxicity.

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

11 active clinical trials are presently analyzing the potential of Sevelamer Carbonate to address Hyperphosphataemia.

Condition

Clinical Trials

Trial Phases

Hyperphosphataemia

0 Actively Recruiting

Hemodialysis

13 Actively Recruiting

Not Applicable, Phase 2

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

1

Patient Review

3/28/2011

Sevelamer Carbonate for Renal Osteodystrophy with Hyperphosphatemia

I had a really unfortunate reaction to this treatment and would not recommend it to others.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about sevelamer carbonate

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

What drug class is sevelamer carbonate?

"Renvela is a prescription medicine used to treat the symptoms of Serum Phosphorus Regulation in patients with chronic kidney disease (CKD) who are on dialysis. Renvela may be used alone or with other medications. Renvela belongs to a class of drugs called PO4 Scavengers."

Answered by AI

What are the side effects of sevelamer?

"You may experience headaches, diarrhea, stomach upsets, nausea, vomiting, coughing, gas, or constipation. If you experience any of these effects for an extended period of time, talk to your doctor or pharmacist."

Answered by AI

What is sevelamer carbonate taken for?

"This medicine is only available with a doctor's prescription and is used to treat hyperphosphatemia (too much phosphate in the blood) in patients with chronic kidney disease who are on dialysis."

Answered by AI

When should you take sevelamer?

"Sevelamer is available as a tablet or powder for suspension, which is generally taken three times a day with meals."

Answered by AI

Clinical Trials for Sevelamer Carbonate

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

Have you considered Sevelamer Carbonate clinical trials?

We made a collection of clinical trials featuring Sevelamer Carbonate, we think they might fit your search criteria.
Go to Trials
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Comprehensive Pre-ESKD Education for Chronic Kidney Disease

18+
All Sexes
Gainesville, FL

This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.

Waitlist Available
Has No Placebo

North Florida/South Georgia Veterans Health System, Gainesville, FL

Ashutosh M. Shukla, MD MBBS