Renvela

Hyperphosphataemia, Hemodialysis

Treatment

2 FDA approvals

10 Active Studies for Renvela

What is Renvela

Sevelamer

The Generic name of this drug

Treatment Summary

Sevelamer, sold under the brand name Renagel, is a medication used to prevent excess phosphate from building up in the blood of people with chronic kidney failure.

Renagel

is the brand name

image of different drug pills on a surface

Renvela 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 Renvela Affects Patients

People with end-stage kidney disease often have too much phosphorus in their bodies, which can cause calcium to build up in the wrong places and lead to more serious conditions. This extra phosphorus can also cause high levels of parathyroid hormone, which can cause bone diseases like osteitis fibrosa. To help with this, doctors can prescribe Sevelamer, a medicine that helps reduce phosphorus levels in the body. It is usually taken with meals and has been shown to lower phosphorus levels in people on dialysis. It also helps lower bad cholesterol (LDL) and total cholesterol levels.

How Renvela works in the body

Sevelamer stops too much phosphate from entering the body. It does this by binding to dietary phosphate in the gut, stopping it from being absorbed. This lowers the amount of phosphate in the bloodstream, which in turn lowers the levels of a hormone that controls phosphate levels.

When to interrupt dosage

The recommended measure of Renvela is contingent upon the diagnosed health issue. The dosage fluctuates as per the method of delivery (e.g. Parenteral or Capsule) highlighted in the below 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 Renvela.

Common Renvela 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.

Renvela Toxicity & Overdose Risk

Sevelamer has been administered to healthy volunteers at doses of up to 14 grams per day for 8 days, and to hemodialysis patients at doses up to 13 grams per day without any reported adverse effects. Since sevelamer is not absorbed into the body, the risk of systemic toxicity is low, and there have been no reported overdoses in patients.

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

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

11 current trials are examining the potential of Renvela to mitigate Hyperphosphataemia.

Condition

Clinical Trials

Trial Phases

Hyperphosphataemia

0 Actively Recruiting

Hemodialysis

13 Actively Recruiting

Not Applicable, Phase 2

Renvela Reviews: What are patients saying about Renvela?

5

Patient Review

6/28/2012

Renvela for Renal Osteodystrophy with Hyperphosphatemia

I've been on this medication for about a year now, and unfortunately the constipation has gotten progressively worse. I take four pills with food, but my last phosphorus reading was 10.2. I eat healthy and have a bowel movement only once or twice a week. My blood pressure has also been running low since starting this medication (80/40), so I stopped taking it today. They gave me Fosrenol as an alternative, but I'm afraid to try it because it's in the same class of medications with similar side effects. Does anyone have any recommendations?

5

Patient Review

1/9/2013

Renvela for Renal Osteodystrophy with Hyperphosphatemia

I experienced some stomach upset, but the medication was effective. I didn't like how often I had to take it, and there were some unknown side effects. However, overall I was pleased with the results.

5

Patient Review

6/6/2014

Renvela for Renal Osteodystrophy with Hyperphosphatemia

Since taking this medication, I've been suffering from dry mouth and constipation. It's become a real problem; I have to take two pills after every meal just to get by.

3.7

Patient Review

1/18/2011

Renvela for Renal Osteodystrophy with Hyperphosphatemia

This medication caused me some bad diarrhea at first, but adding Hyomax has helped a lot. I'm still new to dialysis so time will tell how well this treatment works long term.

3.7

Patient Review

2/19/2014

Renvela for Renal Osteodystrophy with Hyperphosphatemia

I've been taking this medication since March 2012 with no issues.

3.3

Patient Review

3/17/2009

Renvela for Renal Osteodystrophy with Hyperphosphatemia

3.3

Patient Review

6/16/2011

Renvela for Renal Osteodystrophy with Hyperphosphatemia

I experienced some major stomach pains and constipation while taking this medication. I decided to switch to another drug, but that caused even more problems.

2.7

Patient Review

3/1/2009

Renvela for Renal Osteodystrophy with Hyperphosphatemia

2.7

Patient Review

7/6/2014

Renvela for Renal Osteodystrophy with Hyperphosphatemia

I've been using Renvela for six months now with good results. My blood work has come back normal and I haven't had any negative side effects that I'm aware of. All in all, I'm pretty pleased with this medication.

2.3

Patient Review

11/15/2008

Renvela for Renal Osteodystrophy with Hyperphosphatemia

1.3

Patient Review

5/25/2011

Renvela for Renal Osteodystrophy with Hyperphosphatemia

From my limited experience, this seemed to work well.

1

Patient Review

2/26/2018

Renvela for Renal Osteodystrophy with Hyperphosphatemia

We're really worried about my mother since she started taking this medication and her blood pressure has been spiking to dangerous levels.

1

Patient Review

4/20/2015

Renvela for Renal Osteodystrophy with Hyperphosphatemia

Taking three pills three times daily made me feel lightheaded at times.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about renvela

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

What type of medication is Renvela?

"Renvela is a prescription medication used to relieve symptoms associated with an imbalance of phosphorus in the blood for CKD patients who are undergoing dialysis. It may be used in conjunction with other drugs, and is classified as a phosphorus scavenger."

Answered by AI

What is the medication Renvela used for?

"High phosphate levels may cause serious medical problems such as weak bones, joint pain, calcification of soft tissues, and heart disease. Sevelamer works by adsorbing phosphate from your gastrointestinal tract, so it is important to take sevelamer with meals or snacks.

Generic Name: sevelamer carbonate

Sevelamer is used to lower high blood phosphate levels in patients who are on dialysis due to severe kidney disease. Dialysis helps to remove some phosphate from the blood, but it is difficult to remove enough to keep phosphate levels balanced. High phosphate levels can cause serious medical problems such as weak bones, joint pain, calcification of soft tissues, and heart disease. Sevelamer works by adsorbing phosphate from the gastrointestinal tract. It is important to take sevelamer with meals or snacks."

Answered by AI

When should Renvela be taken?

"You should take Renvela three times a day with meals to help control phosphorus levels in your body. Renvela binds to phosphorus in the foods you eat and then carries it through your digestive tract and out of your body."

Answered by AI

Why do kidney patients take Renvela?

"Renvela may be used as a first-line treatment for controlling phosphorus levels in the blood of patients with chronic kidney disease who rely on dialysis. It is important to control phosphorus levels in the blood of patients receiving dialysis."

Answered by AI

Clinical Trials for Renvela

Image of Stanford University in Stanford, United States.

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 Renvela clinical trials?

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