Is NCT04580420 recruiting in Boston, MA?

Yes, NCT04580420 is currently recruiting participants at its Boston, MA location. This primary hyperoxaluria type 1 clinical trial is actively enrolling qualified participants.

How do I join the primary hyperoxaluria type 1 clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Primary Hyperoxaluria Type 1 Clinical Trial in Boston, MA

Who Can Participate

Inclusion Criteria

Four age groups of participants will be enrolled:

adults and adolescents (aged ≥ 12 years)

children 6 to 11 years of age

children 2 to 5 years of age

infants and newborns from birth to \< 2 years of age

. Documented diagnosis of PH1, confirmed by genotyping

Estimated GFR at Screening \<30mL/min normalized to 1.73m\^2 BSA

Mean of 2 Plasma Oxalate \>20μmol/L during screening

For participants receiving hemodialysis or peritoneal dialysis total duration of hemodialysis or peritoneal dialysis must be less than 24 months and hemodialysis or peritoneal dialysis regimen must have been stable for at least 2 weeks prior to Screening.

Male or Female

Male participants:

A male participant with a female partner of childbearing potential must agree to use contraception during the treatment period and for at least 12 weeks after the last dose of study intervention and refrain from donating sperm during this period.

Female participants:

A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP).

A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 12 weeks after the last dose of study intervention and agrees to refrain from harvesting/freezing eggs during this period.

Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Participant (and/or participant's parent or legal guardian if participant is a minor \[defined as patient \<18 years of age, or younger than the age of majority according to local regulations\]) is capable of giving signed informed consent, which includes compliance with the requirement and restrictions listed in the informed consent form (ICF) and in the protocol.

Adolescents (12 to \< 18 years of age, or older than 12 years but younger than the age of majority according to local regulations) must be able to provide written assent for participation.

For children younger than 12 years of age, assent will be based on local regulations

Affiliated with or is a beneficiary of a health insurance system (if applicable per national regulations)

Exclusion Criteria

Prior hepatic transplantation; or scheduled transplantation within 6 months of Day 1. Prior renal transplantation is allowed.

Documented evidence of clinical manifestations of severe systemic oxalosis (including preexisting retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations)

Presence of any condition or comorbidities that would interfere with study compliance or data interpretation or potentially impact patient safety including, but not restricted to:

Severe intercurrent illness

Known causes of active liver disease/injury (e.g., alcoholic liver disease, nonalcoholic fatty liver disease/steatohepatitis)

Non-PH related conditions contributing to renal insufficiency

Physician concerns about intake of drugs of abuse or excessive alcohol intake, or history of excessive alcohol intake in the 2 years prior to enrollment (defined as ≥ 21 units of alcohol per week in men and ≥ 14 units of alcohol per week in women; where a "unit" of alcohol is equivalent to a 12-ounce beer, 4-ounce glass of wine, or 1ounce shot of hard liquor)

Use of an RNAi drug, other DCR-PHXC, within the last 6 months

History of one or more of the following reactions to an oligonucleotide-based therapy:

Severe thrombocytopenia (platelet count ≤ 100,000/µL)

Hepatotoxicity, defined as alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 times the upper limit of normal (ULN) and total bilirubin \> 2 × ULN or international normalized ratio (INR) \>1.5

Severe flu-like symptoms leading to discontinuation of therapy

Localized skin reaction from the injection (graded severe) leading to discontinuation of therapy

Coagulopathy/clinically significant prolongation of clotting time

Participation in any clinical study in which they received an investigational medicinal product (IMP) other than DCR-PHXC within 4 months before Screening.

Liver function test abnormalities: ALT and/or AST \>1.5 × ULN for age and gender

Positive anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibody test at Screening

Known hypersensitivity to DCR-PHXC or any of its ingredients

Inability or unwillingness to comply with the specified study procedures, including the lifestyle considerations

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT04580420) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Primary Hyperoxaluria Type 1 Treatment Options in Boston, MA

If you're searching for primary hyperoxaluria type 1 treatment options in Boston, MA, this clinical trial (NCT04580420) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced primary hyperoxaluria type 1 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all primary hyperoxaluria type 1 clinical trials near you to find additional studies recruiting in your area.

Primary Hyperoxaluria Type 1 Clinical Trial in Boston, MA

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About This Primary Hyperoxaluria Type 1 Study in Boston