MK-2060 for Kidney Failure, Chronic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
ASST Grande Ospedale Metropolitano Niguarda ( Site 0953), Milano, Italy
Kidney Failure, Chronic+3 More
MK-2060 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug can prevent blood clots in people with ESRD.

See full description

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Kidney Failure, Chronic

Study Objectives

This trial is evaluating whether MK-2060 will improve 1 primary outcome and 4 secondary outcomes in patients with Kidney Failure, Chronic. Measurement will happen over the course of From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 17 months.

Month 17
Time to First AVG Thrombosis Event
Month 17
Number of AVG Thrombosis Events
Number of Participants Who Discontinue Study Intervention Due to an AE
Month 20
Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria
Number of Participants who Experience One or More Adverse Events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Kidney Failure, Chronic

Trial Design

3 Treatment Groups

MK-2060 High Dose
1 of 3
MK-2060 Low Dose
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 489 total participants across 3 different treatment groups

This trial involves 3 different treatments. MK-2060 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

MK-2060 High Dose
Drug
MK-2060 high dose administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
MK-2060 Low Dose
Drug
MK-2060 low dose administered via intravenous (IV) infusion as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1
Placebo
Drug
Placebo (normal saline) administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-2060
2019
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 20 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 20 months for reporting.

Closest Location

University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595) - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Current diagnosis of ESRD.
Patients will receive hemodialysis three times a week for at least three hours per session via a mature, functioning AVG show original
A woman who is not pregnant or breastfeeding, not of child-bearing potential, or is of child-bearing potential and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention. show original

Patient Q&A Section

Can kidney diseases be cured?

"Results from a recent paper of our study suggest that curing kidney diseases is not possible as they are for other diseases. In order to attain cure, further studies would be useful." - Anonymous Online Contributor

Unverified Answer

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

"Around 1 million Americans are diagnosed with kidney diseases each year, and over 17 million have one or more chronic kidney conditions. About 35,000 Americans die of kidney disease every year. Most deaths occur among African-Americans, Asians, Latinos, Hispanics, and Native Americans; most African-Americans have chronic kidney diseases." - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney diseases?

"Many kidney diseases are first noticed when symptoms do not respond to typical treatments. In most of the kidney diseases, initial symptoms remain unexplained. A complete physical examination will identify signs which are easy to remember and indicate severity of the condition. Some of the signs are specific to particular kidney diseases. Patients with protein in the urine, e.g. nephrolithiasis, hematuria and proteinuria require further examination." - Anonymous Online Contributor

Unverified Answer

What is kidney diseases?

"It is widely recognized that a disease can be diagnosed correctly when the patient exhibits a set of the following criteria (i.e., classic manifestation of the disease): a) a significant increase in creatinine values in a healthy patient (e.g., 0.2-µmol/l) (2.5 mL/min); b) a decrease in creatinine values to 0." - Anonymous Online Contributor

Unverified Answer

What are common treatments for kidney diseases?

"Treatment for kidney disease is based upon the presence of the disease, the type and severity of the disease as well as the age of patient. Patients diagnosed with diabetic nephropathy may require ACE inhibitors, angiotensin antagonists, or angiotensin receptor antagonists. Patients with the end stage kidney diseases require dialysis. Patients suspected to have kidney disease should undergo examination by a physician. For example, patients with high blood pressure and enlarged spleen or/and liver should undergo laboratory test. The key determinants in the treatment of kidney disorder include level of control of blood pressure and the choice of medications." - Anonymous Online Contributor

Unverified Answer

What causes kidney diseases?

"The data suggest that kidney disease is often multifactorial and related to factors inherent in the individual, to the environment and to the society. The present data should initiate a comprehensive approach to prevention and treatment of kidney disease." - Anonymous Online Contributor

Unverified Answer

Does mk-2060 improve quality of life for those with kidney diseases?

"Recent findings for the first time provides evidence that MK-2060 can improve the quality of life in patients with chronic kidney disease and provides a framework for how to proceed with future, larger, trials to understand whether topical MK-2060 can ameliorate the severity of chronic kidney disease in patients with chronic kidney disease." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in mk-2060 for therapeutic use?

"Mk-2060 is a new drug that has been developed by Microkinetics and has the potential to be efficacious as a novel therapeutically active agent in the treatment of nephrotic syndrome. In vitro, Mk-2060 can inhibit the pro-inflammatory effects of TNF-alpha, as well as the pro-fibrinolytic activity of Tissue Factor." - Anonymous Online Contributor

Unverified Answer

How serious can kidney diseases be?

"[Treatment of kidney diseases is important for the preservation of the function of the kidneys and reduction of the risk of irreversible damage in later stages. This is especially true for high blood pressure with proteinuria as a result of which the progression of the disease is fast, and the need for dialysis is high.] (http://www.kidney.org/content/115/5/2211) question: Is type A personality associated with subclinical cardiovascular disease in non-diabetic adults? answer: Type A personality is strongly associated with subclinical CVD in non-diabetic individuals. Although more research is needed, this finding supports evidence that high BP may precede the onset of the disease." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating kidney diseases?

"Currently, [many therapies are used to treat kidney disease and there is still great need for research in kidney disease (Cicatrix) and nephrology (Nephrology) in general. (https://www.ncbi.nlm.nih.gov/books/NBK351159." - Anonymous Online Contributor

Unverified Answer

Does kidney diseases run in families?

"Data from a recent study suggest the kidney diseases seem to run on family lines in the Chinese population. Therefore, the risk of development of a specific disease in an affected relative should be considered during genetic counselling." - Anonymous Online Contributor

Unverified Answer

Is mk-2060 typically used in combination with any other treatments?

"Currently MK-2060 is used alongside conventional treatment for patients with advanced cancer. There has not been much analysis of the optimal dosing regimen for cancer yet many groups are using a fixed dose and it has not been studied in cancer in more than 1 dosing schedule. This is one of the many reasons that the European Medicines Agency have declared a need for more safety and efficacy data on MK-2060. For the treatment of kidney tumors, MK-2040 should also be considered to be dosed in a titration style with minimal fixed doses as a step to minimising toxicity and side effects. These therapies should be considered in the context of nephron sparing and renal toxicity." - 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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