A Phase 1/2 interventional study of Cystone and Sugar Pill (Placebo) in Cystinuria and Nephrolithiasis, Calcium Oxalate, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-02-04.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment
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.
Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Subjects must have a measurable stone by CT. The first phase is a double blind, randomized, placebo controlled cross-over of Cystone and placebo for 6 weeks each separated by a 1 week washout. Entry, 6 and 12 week 24 hour urine supersaturations or cystine, pH and sodium determinations will be collected. Then all patients enter an open label phase of 46 weeks, ensuring a 52-week total exposure to Cystone during the 59 week study. Baseline and 1 year stone quantification CT scans will be performed. End points will be changes in urine chemistry/supersaturation and stone burden. Stone burden was measured by CT, quantitatively for stone density and volume. All CT images were also reviewed in a blinded fashion by a radiologist to score each kidney as increased, no change or decreased stone burden.
Statistics and Randomization: Randomization was accomplished using a table provided by the department of statistics to the study coordinator who was blinded as to whether the patients received placebo or Cystone®. Biochemical and supersaturation results were analyzed via a matched pair analysis using the JMP software package (SAS Instituted, Inc.); P values \< 0.05 were deemed significant.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks
Drug: Cystone · Drug: Sugar Pill (Placebo)
Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks
Drug: Cystone · Drug: Sugar Pill (Placebo)
All subjects will receive Cystone for 46 weeks in the open-label period.
Drug: Cystone
Participants will take 2 pills, 2 times a day. Each tablet of Cystone contains: Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg.
Also known as: Uricare
Participants will take 2 pills, 2 times a day for 6 weeks.
24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
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 program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
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
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
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 program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
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
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
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 program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
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
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
Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
Time frame: Baseline, approximately 52 weeks after baseline
Volume of Kidney Stones as Measured on Computerized Tomography
Measurement of kidney stone volume in cubic millimeters.
Time frame: Baseline, approximately 52 weeks after baseline
Change in Stone Burden as Assessed by Radiologist at One Year
Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.
Time frame: Baseline, approximately 52 weeks after baseline
Patients with recurring and analytically confirmed kidney stones were recruited from the Mayo Stone Clinic in Rochester, MN.
| Milestone | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 9 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
| Milestone | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
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 program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
| KJoules/mol | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| CaOx at Baseline | 1.83 ± 0.28 | — |
| CaOx after placebo (6 wks) | 1.83 ± 0.42 | — |
| CaOx after Cystone (6 wks) | 1.87 ± 0.43 | — |
| CaOx at end of Cystone (46 weeks) | 1.78 ± 0.47 | — |
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 program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
| KJoules/mol | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Brushite at Baseline | 0.35 ± 1.04 | — |
| Brushite after placebo (6 wks) | 0.73 ± 0.83 | — |
| Brushite after Cystone (6 wks) | 0.38 ± 0.98 | — |
| Brushite at end of Cystone (46 weeks) | 0.09 ± 1.29 | — |
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 program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
| KJoules/mol | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Hydroxyapatite at Baseline | 4.25 ± 2.02 | — |
| Hydroxyapatite after placebo (6 wks) | 5.03 ± 1.23 | — |
| Hydroxyapatite after Cystone (6 wks) | 4.65 ± 1.86 | — |
| Hydroxyapatite at end of Cystone (46 weeks) | 4.09 ± 2.06 | — |
Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.
| Kidneys | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Right kidney no change in stone burden | 6 | 7 |
| Right kidney stone burden increased | 2 | 2 |
| Right kidney stone burden decreased | 1 | 0 |
| Left kidney no change in stone burden | 2 | 2 |
| Left kidney stone burden increased | 6 | 5 |
| Left kidney stone burden decreased | 1 | 2 |
| mcmol/24 hours | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Cystine at Baseline | — | 2770 ± 947 |
| Cystine after placebo (6 wks) | — | 3183 ± 1898 |
| Cystine after Cystone (6 wks) | — | 2948 ± 2021 |
| Cystine at end of Cystone (46 weeks) | — | 4140 ± 2398 |
Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
| Agatston Score | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Baseline Right Kidney Agatston Score | 49.75 ± 60.24 | 2,107 ± 4,417 |
| 52 week Right Kidney Agatston Score | 56.13 ± 74.23 | 2,183 ± 4,157 |
| Baseline Left Kidney Agatston Score | 166.13 ± 143.16 | 383 ± 560 |
| 52 week Left Kidney Agatston Score | 247.71 ± 371.46 | 1,801 ± 2,741 |
Measurement of kidney stone volume in cubic millimeters.
| mm^3 | Calcium Stone Subjects | Cystine Stone Subjects |
|---|---|---|
| Baseline Right Kidney Stone Volume | 45.5 ± 52.03 | 1,602 ± 3,335 |
| 52 Week Right Kidney Stone Volume | 52.75 ± 66.44 | 1,677 ± 3,139 |
| Baseline Left Kidney Stone Volume | 141.25 ± 198.98 | 301 ± 422 |
| 52 Week Left Kidney Stone Volume | 174.25 ± 265.73 | 2,064 ± 688 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Calcium Stone Subjects | — | 0/10 (0%) | 0/10 (0%) |
| Cystine Stone Subjects | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Calcium Stone Subjects | Cystine Stone Subjects | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 9 | 17 |
| >=65 years | 2 | 1 | 3 |
| Sex: Female, Male(Participants) | Calcium Stone Subjects | Cystine Stone Subjects | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 4 | 6 | 10 |
| Region of Enrollment(participants) | Calcium Stone Subjects | Cystine Stone Subjects | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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