Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Safety: Incidence of Events	180 days	To assess the efficacy of DCR-PHXC in lowering Pox in participants with PH1 and severe renal impairment, with or without hemodialysis or peritoneal dialysis.
Primary	Safety: Incidence of Events	180 days	Characterize the safety of DCR-PHXC in participants with PH1 and severe renal impairment, with or without dialysis.
Secondary	Change from Baseline in Plasma Oxalate Concentration	180 Days	To evaluate the effect of DCR-PHXC on Plasma Oxalate concentration from Baseline to day 180
Secondary	To characterize the PK of DCR PHXC in patients with PH by observing secondary parameters of the area under the curve.	180 days	Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including secondary parameters of area under the curve (AUC)
Secondary	To characterize the PK of DCR PHXC in patients with PH by observing maximum observed concentration (Cmax).	180 days	Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including maximum observed concentration (Cmax)
Secondary	To characterize the PK of DCR PHXC in patients with PH by observing minimum concentration (Cmin).	180 days	Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including minimum observed concentration (Cmin)
Secondary	To characterize the PK of DCR PHXC in patients with PH by observing maximum concentration (Tmax).	180 days	Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including time to maximum concentration (Tmax)
Secondary	To characterize the PK of DCR PHXC in patients with PH by observing terminal elimination half-life (t1/2).	180 days	Population and individual pharmacokinetic (PK) parameters for DCR PHXC, including terminal elimination half-life (t1/2)
Secondary	Change in Frequency of Dialysis	180 days	Change from Baseline in the frequency of dialysis over 180 days
Secondary	Change in Duration of Dialysis	180 days	Change from Baseline in the duration of dialysis over 180 days
Other	Change from Baseline in the Short Form (36) Health Survey (SF-36®) in adults	180 days	To evaluate the effect of DCR-PHXC on Quality of Life (QoL) assessments in patients with PH. The SF 36 is a set of generic, coherent, and easily administered quality-of-life measures that taps 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The 36 items are identical to the MOS SF 36 described in Ware and Sherbourne (1992). Participants respond to each item on a categorical scale. Categorical answers are transformed to a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state
Other	Change from Baseline in the EQ-5D-5L™ in adults	180 days	To evaluate the effect of DCR-PHXC on Quality of Life (QoL) assessments in patients with PH. The EQ-5D-5L consists of the EQ 5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the 5 dimensions can be combined into a 5-digit number that describes the participant's health state. The EQ VAS records the participant's self-rated health on a 20-cm vertical VAS, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine.' Participants are asked to place an "X" on the line that represents their health on that day.
Other	Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL™) in children	180 days	To evaluate the effect of DCR-PHXC on Quality of Life (QoL) assessments in patients with PH. The 23-item PedsQL is comprised of 5 items in the Emotional, Social, and School Functioning dimensions (Psychosocial Health) and 8 items in the Physical Functioning (Physical Health) dimension. Items are reverse-scored on a 0 to 4 Likert scale and linearly transformed to a 0 to 100 scale, so that higher scores indicate better functioning and HRQOL. Scale Scores are the sum of the items in each dimension, divided by the number of items answered.
Other	Changes from Baseline number of kidney stones	180 days	Evaluate the effect of DCR-PHXC on stone burden in participants with PH1 and severe renal impairment through Kidney Ultrasound
Other	Changes from Baseline size of kidney stones	180 days	Evaluate the effect of DCR-PHXC on stone burden in participants with PH1 and severe renal impairment through Kidney Ultrasound

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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