A Phase 3 interventional study of Sodium Thiosulfate and Placebo-Normal Saline in Calciphylaxis, sponsored by Hope Pharmaceuticals. Terminated at 21 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Hope Pharmaceuticals · Phase 3, Interventional, and Treatment
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients.
This Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Thiosulfate Injection for treatment of acute calciphylaxis-associated pain in chronic hemodialysis patients. Acute calciphylaxis- associated pain intensity will be the primary outcome measure.
23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.
This study's enrollment of 29 is close to the median of 28 across 12 interventional studies indexed under Calciphylaxis.
Browse Calciphylaxis studies →Hope Pharmaceuticals is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sodium Thiosulfate Injection (25 grams sodium thiosulfate)
Drug: Sodium Thiosulfate
0.9% sodium chloride injection, USP (normal saline)
Drug: Placebo-Normal Saline
Intravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks
Also known as: Intravenous Sodium Thiosulfate Injection
Placebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks
Also known as: 0.9% sodium chloride solution
Number of patients with 30% improvement in pain severity
To compare the effects of treatment with intravenous Sodium Thiosulfate Injection vs. placebo for the proportion of patients (responders) who achieve a ≥ 30% reduction based upon pain intensity score (modified BPI/SF).
Time frame: randomization to 3 weeks
Secondary Endpoint-a: Number of patients with stabilization or improvement in calciphylaxis skin lesions.
Proportion of patients who achieve improvement or stabilization (i.e., not worsening) of skin lesions.
Time frame: randomization to 3 weeks
Secondary Endpoint-b: Occurence of surgical debridement of skin lesions and/or amputation.
Occurence of surgical debridement of skin lesions and/or amputation.
Time frame: during week 3
Secondary Endpoint-c: Occurrence of surgical debridement of skin lesions and/or amputation.
Occurrence of surgical debridement of skin lesions and/or amputation.
Time frame: randomization to 3 weeks
Secondary Endpoint-d: Time to achieve ≥ 30% improvement in pain severity
Time in days when a patient achieves a ≥ 30% improvement based upon pain intensity score (modified BPI/SF).
Time frame: randomization to 3 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium thiosulfate
Hope Pharmaceuticals