Renagel

Hyperphosphataemia, Hemodialysis

Treatment

2 FDA approvals

10 Active Studies for Renagel

What is Renagel

Sevelamer

The Generic name of this drug

Treatment Summary

Sevelamer is a medication used to reduce the levels of phosphate in the blood of people with chronic kidney disease. It is sold under the brand name Renagel and is used to prevent high phosphate levels, which can cause serious health problems.

Renagel

is the brand name

image of different drug pills on a surface

Renagel 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 Renagel Affects Patients

People with end-stage renal disease often have too much phosphorus in their blood, which can lead to calcium buildup in the body (called ectopic calcification). High levels of phosphorus can also cause the parathyroid hormone (PTH) levels to increase, which can cause a bone disease called osteitis fibrosa. To treat hyperphosphatemia, doctors may recommend reducing dietary intake of phosphate, taking drugs to block phosphate absorption, and undergoing dialysis. Sevelamer is a medication that can be taken with meals to reduce serum phosphorus levels. Studies have also shown that sevelamer can lower low-density lipoprotein

How Renagel works in the body

Sevelamer stops the body from absorbing too much phosphate from food. This helps keep phosphate levels in the blood from becoming too high.

When to interrupt dosage

The measure of Renagel is contingent upon the determined condition. The measure of dosage fluctuates based on the method of delivery (e.g. Parenteral or Capsule) noted in the table underneath.

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 Renagel.

Common Renagel 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.

Renagel Toxicity & Overdose Risk

Sevelamer has been tested on healthy volunteers at doses of up to 14 grams per day for 8 days with no negative effects. Hemodialysis patients have been given up to 13 grams per day with no reported overdoses. Since sevelamer is not absorbed by the body, there is a low risk of developing systemic toxicity.

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

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

11 active studies are currently evaluating the potential of Renagel in ameliorating Hyperphosphataemia.

Condition

Clinical Trials

Trial Phases

Hyperphosphataemia

0 Actively Recruiting

Hemodialysis

13 Actively Recruiting

Not Applicable, Phase 2

Renagel Reviews: What are patients saying about Renagel?

4.7

Patient Review

11/21/2009

Renagel for High Amount of Phosphate in the Blood

I've been using Renagel for my dialysis treatments for the past 8 years and it has really helped to control my phosphorus levels. I typically take 5 tablets with each meal that contains protein. I haven't experienced any negative side effects and, although it is quite expensive, I would rather pay for this than risk long-term organ damage from something like Phoslo.

4

Patient Review

12/27/2008

Renagel for Renal Osteodystrophy with Hyperphosphatemia

I had been taking Renagel to control my high phosphorus levels due to kidney failure, but it was very expensive and ineffective. When the doctors switched me to Phoslo, my phosphorus level dropped to an acceptable level.

3.7

Patient Review

6/24/2011

Renagel for High Amount of Phosphate in the Blood

By my doctor's recommendation, I tried this treatment.

3.7

Patient Review

6/7/2008

Renagel for Renal Osteodystrophy with Hyperphosphatemia

3.3

Patient Review

5/7/2008

Renagel for High Amount of Phosphate in the Blood

2.7

Patient Review

7/5/2009

Renagel for High Amount of Phosphate in the Blood

I find that taking Renagel 800mg constipates me and causes rectal bleeding. I take two tablets after each meal, which can be up to six per day. This results in bright red blood during bowel movements, which is sometimes accompanied by the feeling that I need to have a bowel movement.

2.7

Patient Review

11/8/2009

Renagel for High Amount of Phosphate in the Blood

Renagel has been successful in lowering my phosphate levels; however, I am now frequently experiencing heartburn, especially in the morning. It's not a fun way to wake up!

2.3

Patient Review

10/4/2009

Renagel for High Amount of Phosphate in the Blood

My husband has been taking this medication for approximately one month to help lower his phosphate level. However, he has frequently experienced nausea and vomiting, as well as changes in taste since starting the medication. He is requesting to go back on Phoslo.

2.3

Patient Review

2/21/2011

Renagel for High Amount of Phosphate in the Blood

I'm not a fan of this medication because it seems to have caused constipation.

1.7

Patient Review

12/18/2008

Renagel for Renal Osteodystrophy with Hyperphosphatemia

This treatment isn't always effective, but seems to work better when used in conjunction with Alumin Hydroxode liquid.

1

Patient Review

2/15/2009

Renagel for High Amount of Phosphate in the Blood

This medication has been ineffective in controlling my itch, and if anything, it seems to be getting worse. I've already had to increase the dosage once at the recommendation of my doctor, but it doesn't seem to be helping.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about renagel

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

What is the difference between Renagel and Renvela?

"The next generation of Renagel, called Renvela, is just as effective in controlling serum phosphorus levels in patients with CKD, but has the added benefit of a carbonate buffer."

Answered by AI

What is Renagel used to treat?

"Sevelamer works by binding with phosphate in your intestine so that it is not absorbed into your blood.

Generic name: sevelamer HCL Sevelamer is used to lower high blood phosphorus (phosphate) levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Sevelamer works by binding with phosphate in your intestine so that it is not absorbed into your blood."

Answered by AI

Does Renagel cause constipation?

"If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

The following is a brief summary of the drug for the patient or caregiver from First DataBank. SIDE EFFECTS: Headache, diarrhea, stomach upset, nausea, vomiting, cough, gas, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly."

Answered by AI

What is Renagel 800 mg used for?

"Renagel is a medication used to help adult kidney failure patients on dialysis to control the levels of phosphate in their blood."

Answered by AI

Clinical Trials for Renagel

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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

Image of DCI Desert Dialysis in Tucson, United States.

"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 Renagel clinical trials?

We made a collection of clinical trials featuring Renagel, we think they might fit your search criteria.
Go to Trials