56 Participants Needed

Prevention Strategies for Kidney Stones

RH
BL
BD
Overseen ByBrianne Duncan, RN
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods to prevent kidney stones in patients who have had multiple episodes. One method uses specific urine tests to guide treatment, while the other uses a general treatment approach. Both methods involve diet changes and medications to reduce stone-forming substances in the urine. Recognized medications for preventing kidney stone recurrence include thiazide diuretics, allopurinol, and potassium citrate.

Will I have to stop taking my current medications?

The trial excludes participants who are using specific medications like thiazides, topiramate, xanthine oxidase inhibitors, citrate, and bicarbonate. If you are taking any of these, you may need to stop them to participate.

Is potassium citrate safe for preventing kidney stones?

Potassium citrate is generally considered safe when used at therapeutic doses, with good tolerance and no significant side effects reported in studies. Some mild changes in blood chemistry may occur, but no serious complications like gastrointestinal upset or cardiopulmonary discomfort have been observed.12345

What makes the drug potassium citrate unique for preventing kidney stones?

Potassium citrate is unique because it helps prevent kidney stones by alkalinizing (making less acidic) the urine, which can reduce the formation of certain types of stones like calcium oxalate and uric acid stones. It is particularly effective for patients with low citrate levels in their urine, a condition known as hypocitraturia.35678

What data supports the effectiveness of the drug potassium citrate for preventing kidney stones?

Research shows that potassium citrate is effective in preventing kidney stones, particularly calcium oxalate and calcium phosphate stones, by increasing urinary citrate levels and alkalinizing urine, which helps prevent stone formation.13567

Who Is on the Research Team?

RH

Ryan Hsi, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who've had two or more painful kidney stone episodes in the past five years. It's not suitable for those with certain kidney conditions, untreated urinary blockages, specific metabolic disorders, pregnancy, inflammatory bowel disease or related surgeries, sarcoidosis, cystinuria, severe chronic kidney disease (eGFR<60), frequent gout attacks, allergies to study meds or imbalances in blood potassium/sodium.

Inclusion Criteria

I am 18 years old or older.
I have had two or more painful kidney stone episodes in the past 5 years.

Exclusion Criteria

My kidney function is reduced (eGFR<60).
I have a blockage in my urinary system that hasn't been treated.
Known allergy to study medications
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either empiric diet plus thiazide with potassium citrate daily, or to selective diet plus pharmacologic therapy based on 24-hour urine abnormalities.

8 weeks
Baseline, 1 month, and 2 months

Follow-up

Participants are monitored for changes in urinary supersaturation and adverse effects from the treatment strategies.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Empiric Therapy: Diet
  • Empiric Therapy: Drug
  • Selective Therapy: Diet
  • Selective Therapy: Drug
Trial Overview The study compares two approaches to prevent new kidney stones: 'Selective Therapy' which tailors diet and drugs to individual needs versus 'Empiric Therapy' that uses a general diet and medication plan. Participants are randomly assigned to one of these strategies.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Selective TherapyExperimental Treatment2 Interventions
Diet intervention and drug intervention based on 24 hour urine results
Group II: Empiric TherapyActive Control2 Interventions
Diet intervention and drug intervention not based on 24 hour urine results

Empiric Therapy: Diet is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Urocit-K for:
  • Renal tubular acidosis
  • Hypocitraturic calcium oxalate nephrolithiasis
  • Uric acid lithiasis with or without calcium stones
🇪🇺
Approved in European Union as Cytra-K for:
  • Renal tubular acidosis
  • Hypocitraturic calcium oxalate nephrolithiasis
  • Uric acid lithiasis with or without calcium stones

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Published Research Related to This Trial

In a study of 70 asymptomatic urolithiasis patients, a combination of potassium citrate (K-Cit) and magnesium chloride (MgCl2) significantly reduced urinary stone size compared to K-Cit alone after 4 weeks of treatment.
The mean urinary stone size decreased from 5.1 ± 0.8 mm to 2.5 ± 1.2 mm in the group receiving the combination therapy, indicating that this combination may be a more effective treatment option for managing urinary stones.
Evaluating the effectiveness of adding magnesium chloride to conventional protocol of citrate alkali therapy on kidney stone size.Niroomand, H., Ziaee, A., Ziaee, K., et al.[2020]
In a study of 15 patients treated with granulated potassium citrate for one month, significant biochemical changes were observed, including improvements in serum potassium, creatinine, and urinary pH, citrate, and potassium levels.
The treatment was well tolerated, confirming that potassium citrate is an effective and user-friendly option for preventing oxalocalcium kidney stones.
[Granulated potassium citrate in the prevention of calcium oxalate lithiasis].Campoy Martínez, P., Arrabal Martín, M., Quintero Rodríguez, R., et al.[2013]
K-CITEK, a new potassium-citrate regimen, was found to be equally effective as UROCIT-K in preventing kidney stones, based on a study of 104 patients.
Both treatments showed no significant differences in urinary citrate levels, stone burden, or the frequency of kidney stone events, indicating that K-CITEK is a viable alternative to UROCIT-K.
[A COMPARISON BETWEEN TWO POTASSIUM CITRATE REGIMENS FOR THE TREATMENT OF NEPHROLITHIASIS].Drori, T., Abu-Ghanem, Y., Kleinmann, N., et al.[2020]

Citations

Evaluating the effectiveness of adding magnesium chloride to conventional protocol of citrate alkali therapy on kidney stone size. [2020]
[Granulated potassium citrate in the prevention of calcium oxalate lithiasis]. [2013]
[A COMPARISON BETWEEN TWO POTASSIUM CITRATE REGIMENS FOR THE TREATMENT OF NEPHROLITHIASIS]. [2020]
New drug therapy for kidney stones: a review of cellulose sodium phosphate, acetohydroxamic acid, and potassium citrate. [2019]
Citrate and renal calculi. [2013]
6.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
[Clinical study of Urocit-K: a slow releasing potassium citrate]. [2015]
[Therapeutic use of potassium citrate]. [2022]
Potassium citrate vs. hydrochlorothiazide to reduce urinary calcium excretion in calcium oxalate stone patients with hypercalciuria: a prospective randomized study. [2022]
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