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Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

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ClinicalTrials.gov Identifier: NCT03391804
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Allena Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 2, 2018
First Posted Date  ICMJE January 5, 2018
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE July 17, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
Change in plasma oxalate [ Time Frame: on 12 weeks of treatment ]
Efficacy will be assessed based on change from baseline in plasma oxalate
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03391804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
Change in 24-hr urinary oxalate excretion [ Time Frame: on 12 weeks of treatment ]
Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Official Title  ICMJE Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Brief Summary Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria
Detailed Description

Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .

Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Enteric Hyperoxaluria
  • Primary Hyperoxaluria
  • Hyperoxalemia
Intervention  ICMJE Drug: ALLN-177
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
Other Name: Oxalate decarboxylase
Study Arms  ICMJE Experimental: ALLN-177
ALLN-177 7,500 units (2 capsules)
Intervention: Drug: ALLN-177
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed a informed consent form or an assent
  2. Aged 12 or older with body weight ≥ 35kg
  3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
  4. Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2
  5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening
  6. In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening
  7. Patients on dialysis, must be stable for greater than 3 months

Exclusion Criteria:

1. Unable or unwilling to discontinue Vitamin C supplementation

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allena Communication Center 617-467-4577 ext 397 clinical206@allenapharma.com
Listed Location Countries  ICMJE Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03391804
Other Study ID Numbers  ICMJE ALLN-177-206
2017-003547-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Allena Pharmaceuticals
Study Sponsor  ICMJE Allena Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Annamaria Kausz, MD MS Allena Pharmaceuticals Inc
PRS Account Allena Pharmaceuticals
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP