Treatment for Kidney Failure, Chronic

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Philippines General Hospital, Ermita, Philippines
Kidney Failure, Chronic+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether spironolactone is effective in preventing heart failure and heart related deaths in dialysis patients.

See full description

Eligible Conditions

  • Kidney Failure, Chronic
  • End Stage Renal Disease (ESRD)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Kidney Failure, Chronic. Measurement will happen over the course of up to 5 years.

up to 5 years
All-cause Hospitalization
All-cause death
CV Death or Hospitalization for Heart Failure
Cause specific death
Hospitalization for Heart Failure
Hospitalization for hyperkalemia

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Spironolactone 25 MG Tablet
1 of 2
Placebo Oral Tablet
1 of 2
Active Control
Non-Treatment Group

This trial requires 2750 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Placebo Oral Tablet
Drug
A tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance
Spironolactone 25 MG Tablet
Drug
25 mg of active spironolactone in tablet form

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Hopital du Sacre-Coeur de Montreal - Montreal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age
People who are ≥45 years old or ≥18 years old and have a history of diabetes are at risk for developing AMD. show original
This means that the person has been on dialysis for at least 90 days. show original
On either
Hemodialysis is prescribed at least two treatments per week, or peritoneal dialysis is prescribed with at least one exchange daily. show original
Provides informed consent

Patient Q&A Section

Has treatment proven to be more effective than a placebo?

"Data from a recent study of the trials provide support for conclusions that the standard of care regimen is highly effective from the patients' perspective." - Anonymous Online Contributor

Unverified Answer

What causes kidney diseases?

"Infections with pathogens such as tuberculosis and syphilis can cause kidney diseases. Furthermore, the development of nephritis can occur in people whose immune systems have failed to eliminate these pathogens. Diabetes, high blood pressure and tobacco smoking are all risk factors for kidney diseases." - Anonymous Online Contributor

Unverified Answer

How many people get kidney diseases a year in the United States?

"Over 12.9 million US adults are estimated to have CKD. This makes up about 7.1% of the adult population. Approximately 9.6 million individuals with CKD have some degree of end stage kidney disease. The most common cause of CKD is hypertension. CKD is on the rise among the United States population with a rate of increase between 1.5% and 2.0% per year. This increasing trend has been observed since 1980, and is now accelerating at four times the normal rate." - Anonymous Online Contributor

Unverified Answer

What is kidney diseases?

"Kidney disease was common in adults in the USA, affecting 1 in 9 people living in the USA in 2000 and affecting 1 in 4 people between the age of 5 and 64 years. The majority of people would have preferred to keep their kidney disease secret. They reported significant impact of living with kidney disease on family, work and other social and economic considerations. A national initiative to support people living with kidney disease may reduce associated personal, social and economic burden." - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney diseases?

"Results from a recent clinical trial has shown that serum creatinine is the only independent predictor of mortality in patients with CKD. Other factors such as proteinuria should be considered in more specific contexts. We also found no relationship between the occurrence of CKD and a particular risk factor, although there was a strong association of diabetes." - Anonymous Online Contributor

Unverified Answer

Can kidney diseases be cured?

"Although kidney diseases are highly prevalent, they are not inevitable. The development of kidney disease could be prevented at early stages, if there are no aggravating factors, such as smoking, and if the person seeks and completes an appropriate treatment for the cause of the disease. The treatment is only effective and feasible if the causative factors are removed while the disease is still reversible." - Anonymous Online Contributor

Unverified Answer

What are common treatments for kidney diseases?

"Various techniques are used to treat kidney diseases, including dietary restrictions, blood or drug restriction, and avoidance of certain kinds of substances. There is a need to make more information about the effects of drug use and the use of certain herbal medicines and foods so that people can minimize potential harm in their everyday lives." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of kidney diseases?

"The primary cause of kidney diseases is an imbalance between high concentration of uric acid in the urine and water losses due to perspiration. The loss of water due to perspiration is an important fact, particularly in elderly persons. As for the high concentration of uric acid in the urine, it occurs as a consequence of an increase in the kidney’s excretion of uric acid. The excretion of uric acid is affected by hyperuricemia (high concentration of hyperuricemia in the serum)." - Anonymous Online Contributor

Unverified Answer

How serious can kidney diseases be?

"The condition of chronic kidney disease (CKD) is severe in terms of reduced quality of life, healthcare use, and mortality. Especially in this regard, women seem to present a higher risk of severe disease than males. The prevalence of CKD seems to be steadily increasing, especially in men. Recent findings show that an individual risk factor has been significantly associated with CKD in the general population in both men and women. However, a strong and reproducible association was established only in women." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets kidney diseases?

"There are still several unknown risk factors that contribute to developing kidney diseases and [chronic kidney disease]. Although it seems like the average age people get kidney diseases is steadily increasing, the incidence of kidney diseases differs by gender and ethnicity. Women and African Americans are at a higher risk of developing chronic kidney disease. For men, [blood tests for creatinine(Cr) level] is the most used diagnostic tool to help identify individuals at risk. [CKDATAT:Kidney Disease Network of America Toxicity Score (CKD-USA)] is the first tool that provides an estimation of the risk of developing chronic kidney disease." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating kidney diseases?

"In the last fifteen years, few new drugs for kidney diseases were developed, while in the previous fifteen years, we have seen new drugs for kidney diseases not only for kidney diseases, but also for other renal disorders, such as kidney function and proteinuria with or without renal disorders, as well as for kidney diseases and urinary diseases. So we can say that knowledge of kidney diseases is useful, but knowledge on kidney diseases do not advance very fast." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for kidney diseases?

"Clinical trials for kidney diseases often require significant patient recruitment and monitoring of patients for outcomes; trials with large populations could require years to complete. On the basis of these data, patients who consider a trial should carefully consider possible risks when it is not required for their immediate care needs or they are on a specific therapy that they have ongoing access to." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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