NCT00381849

Cystone for Treatment of Nephrolithiasis

Completed Phase 1/Phase 2 Results posted Last updated 4 January 2016

What this trial tests

Phase 1/Phase 2 trial testing Cystone in Cystinuria in 20 participants. Completed in 1 June 2010.

Timeline

1 April 2006

Primary endpoint
1 September 2009

1 June 2010

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	1 April 2006
Primary completion	1 September 2009
Estimated completion	1 June 2010
Sites	1 location across United States

Drugs / interventions tested

• Cystone — full drug profile →
• Sugar Pill (Placebo) — full drug profile →

Conditions studied

• Cystinuria — all drugs for Cystinuria →
• Nephrolithiasis, Calcium Oxalate — all drugs for Nephrolithiasis, Calcium Oxalate →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 100, any sex, with Cystinuria or Nephrolithiasis, Calcium Oxalate. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
  Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
  Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer p
• 24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
  Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
  Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer p
• 24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
  Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
  Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer p
• 24 Hour Urinary Cystine Excretion
  Time frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
• Stone Density as Measured by Agatston Score Via Computerized Tomography
  Time frame: Baseline, approximately 52 weeks after baseline
  Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
• Volume of Kidney Stones as Measured on Computerized Tomography
  Time frame: Baseline, approximately 52 weeks after baseline
  Measurement of kidney stone volume in cubic millimeters.

Sponsor's own description

We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as Cystone regarding their ability to dissolve existing kidney stones and prevent formation of new ones. Cystine and calcium stone formers will be recruited for a 59 week trial. The first phase of the study will be two 6 weeks periods during which each subject will receive Cystone or placebo in random order (with a one-week wash out between 6 week treatment periods). The remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary chemistries and stone burden by Computerized Tomography (CT) scanning.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cystinuria: genetic aspects, mouse models, and a new approach to therapy.
   Sahota A, Tischfield JA, Goldfarb DS, Ward MD, et al · · 2019 · cited 61× · PMID 30515543 · DOI 10.1007/s00240-018-1101-7