EffCaMgCitrate 480 mg for Chronic Kidney Disease (CKD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UT Southwestern Medical Center, Dallas, TX
Chronic Kidney Disease (CKD)+3 More
EffCaMgCitrate 480 mg - DietarySupplement
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of calcium and magnesium supplements and a diabetes drug can improve kidney and cardiovascular health in people with chronic kidney disease.

See full description

Eligible Conditions

  • Chronic Kidney Disease (CKD)
  • Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Chronic Kidney Disease (CKD)

Study Objectives

This trial is evaluating whether EffCaMgCitrate 480 mg will improve 2 primary outcomes and 2 secondary outcomes in patients with Chronic Kidney Disease (CKD). Measurement will happen over the course of Baseline, 12 weeks.

Baseline, 12 weeks
Change in serum klotho levels at 12 weeks
Change in serum magnesium levels at 12 weeks
Baseline, 24 weeks
Change in serum klotho levels at 24 week
Change in serum magnesium levels at 24 weeks

Trial Safety

Safety Progress

1 of 3

Other trials for Chronic Kidney Disease (CKD)

Trial Design

3 Treatment Groups

Group 3: Dapagliflozin + Placebo EffCaMgCitrate
1 of 3
Group 2: EffCaMgCitrate + Placebo Dapagliflozin
1 of 3
Group 1: Placebo EffCaMgCitrate + Placebo Dapagliflozin
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 36 total participants across 3 different treatment groups

This trial involves 3 different treatments. EffCaMgCitrate 480 Mg 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 1 and are in the first stage of evaluation with people.

Group 3: Dapagliflozin + Placebo EffCaMgCitrateGroup 3 will receive the medication Dapagliflozin10mg (total dosage per day) and Placebo Effervescent CaMgCitrate twice a day.
Group 2: EffCaMgCitrate + Placebo DapagliflozinGroup 2 will receive the medication EffCalMgcitrate 480mg (total dosage per day) and Placebo Dapagliflozin twice a day.
Group 1: Placebo EffCaMgCitrate + Placebo DapagliflozinGroup 1 will receive a Placebo form the Effervescent CaMgCitrate and a Placebo form of the Dapagliflozin twice a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 24 weeks for reporting.

Who is running the study

Principal Investigator
R. T.
Prof. Robert Toto, PROFESSOR
University of Texas Southwestern Medical Center

Closest Location

UT Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Hypertension is defined as a blood pressure reading of greater than 130 mmHg systolic or greater than 80 mmHg diastolic, or as a blood pressure that has been normal on medication. show original
The estimated glomerular filtration rate (GFR) for people with stages 3b-4 CKD is 15-44 ml/min/1.73 m2. show original
The ability of the study participant or their legally authorized representative to provide informed written consent. show original
The group was able to maintain a stable dose of any vitamin D and calcium supplements for 180 days after the randomization. show original
The text states that the age range is 18-80 years old. show original
All races and ethnicities
All genders
Type 2 diabetes mellitus
is an indicator of renal dysfunction A urinary albumin creatinine ratio of more than 200 mg/g is an indicator of renal dysfunction show original
and a decrease in serum magnesium level of > 0.6 mg/dl at any time during the study were predictors of magnesium deficiency show original

Patient Q&A Section

Can kidney diseases be cured?

"Chronic kidney disease is best treated using a combination of interventions. To prevent disease progression, most patients need long-term medication for controlling blood pressure, kidney function, anemia and metabolic abnormalities." - Anonymous Online Contributor

Unverified Answer

Does kidney diseases run in families?

"The present study may provide the scientific evidence to claim a strong genetic connection between kidney disease and heredity, but there is a large variation of genetic predisposition between the disease groups." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for kidney diseases?

"When considering clinical trials, patients should be informed to be aware of the likelihood of benefiting. When deciding whether to participate in a clinical trial, patients should consider the type of trial (monotherapeutic or multitherapeutic), the risk of harm/damage on oneself, and the type of treatment." - Anonymous Online Contributor

Unverified Answer

What is kidney diseases?

"This article outlines the importance of kidney disease, some of the characteristics, and some of the treatments. In the USA, approximately 1/3 of the population has a kidney disease annually. One-half of these people were diagnosed with kidney disease. Most of these end-stage kidney diseases would not go into remission. Power makes it easy to find kidney disease clinical trials tailored to your condition, treatment, or location." - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney diseases?

"Signs of glomerulonephritis and chronic kidney disease can be present as proteinuria, hematuria and/or edema, and this can be present from the time of diagnosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for kidney diseases?

"The most frequent treatment for kidney diseases is substitution therapy with dialysis or transplantation. New discoveries may help us to discover a new treatment option for the people affected with kidney diseases." - Anonymous Online Contributor

Unverified Answer

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

"The National Kidney Data System reported that there have been more than 20,000 new cases of end-stage kidney disease (ESKD) in 2009 compared with 2005. The majority of new cases occurred in patients over the age of 60, with a prevalence of 2.4/1,000 persons > age 75. Between 2005 and 2009, there was an increase, predominantly within older cohorts, in new cases of ESKD. In 2010, there was no evidence linking recent increases in tobacco use with ESKD." - Anonymous Online Contributor

Unverified Answer

What causes kidney diseases?

"The common causes of many kidney disorders include infection, drug-related diseases, metabolic disorders, and dietary factors. A variety of other predisposing and environmental factors can be involved." - Anonymous Online Contributor

Unverified Answer

Does effcamgcitrate 480 mg improve quality of life for those with kidney diseases?

"For patients with CKD or dialysis, effcamgcitrate improves both renal disease-specific and global QOL. Effcamgcitrate may be an under-utilized therapeutic option for patients with CKD and a high risk of QOL impairments." - Anonymous Online Contributor

Unverified Answer

Has effcamgcitrate 480 mg proven to be more effective than a placebo?

"The efficacies of effcamgcitrate 480 mg and a placebo for the treatment of chronic constipation in patients with chronic mild to moderate idiopathic constipation were equivalent." - Anonymous Online Contributor

Unverified Answer

What is effcamgcitrate 480 mg?

"Effcamgcitrate 480 mg is safe, well tolerated, and demonstrates early pharmacodynamic biomarker efficacy in patients with stable, mild-to-moderate chronic kidney disease on chronic hemodialysis. The pharmacodynamic biomarker results are consistent with prior work with effcamgcitrate 240 mg in patients with moderate-to-severe chronic kidney disease. The clinical safety profile of effcamgcitrate 480 mg is comparable to that reported for effcamgcitrate 240 mg." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of effcamgcitrate 480 mg?

"Effcamgcitrate can cause gastrointestinal dysfunction in 4 % of patients; diarrhea in 2 %; stomatitis in 1 %; alopecia in 1 %; urticaria in 1 %; hives in 1 %; and other disturbances in 3 % of patients. In patients receiving more than 480 mg, the side effects most frequent were gastrointestinal dysfunction (5 cases), diarrhea (2), stomatitis (1), headache (1), and dysesthesia (1). Efficacy and tolerability of effcamgcitrate 480 mg were similar to those reported in previous studies. Thus, the observed adverse events were not dose-dependent." - 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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