Secondary HyperparathyroidismPhase 3NCT04994080
A Study to Assess the Efficacy and Safety of Paricalcitol in the Treatment of Chronic Kidney Disease With Secondary Hyperparathyroidism
A Phase 3 study testing Paricalcitol in people with Secondary Hyperparathyroidism, run by Chengdu Suncadia Medicine Co., Ltd..
Trial summary
The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- Paricalcitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 31 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Under care of physician at least 2 months for CKD
- Not on active Vitamin D and Calcimimetic therapy for at least 4 weeks prior
- If taking phosphate binders, on a stable regimen at least 4 weeks prior
- For entry into Pretreatment Phase:
- iPTH at least 120 pg/mL GFR of 15-60 mL/min and no dialysis expected for at least 6 months
- For entry into Treatment Phase:
- Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL) 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL
Who cannot join
- Subjects who had Primary hyperparathyroidism;
- Subjects with a history of acute renal failure;
- Subjects with chronic gastrointestinal disease or severe liver disease with clinical symptoms;
- Subjects with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically meaningful arrhythmia;
- Subjects with serum albumin < 30g/L, serum hemaoglobin < 85g/L, or serum transaminase higher than 2.5 times the upper limit of nomal;
- Subjects with a history of malignancy;
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- Subjects who plan to undergo surgery during the study period;
- Subjects with a history active granulomatous diseases;
- Subject with a history of alcohol abuse and drug abuse;
- Human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab) or Treponema pallidum antibody (TP-Ab) are positive;
- Subjects who are allergic to the test drug and its ingredients or excipients;
- Subjects who combined with systemic or systemic diseases that are not suitable for clinical trials;
- Subjects who have participated in clinical trials of other drugs or devices;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel Grouping, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Paricalcitol Soft Capsules in the Treatment of Secondary Hyperparathyroidism in Subjects With Stage 3 and Stage 4 Chronic Kidney Disease
The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Paricalcitol, Placebo
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Paricalcitol QD Treatment
PlaceboDrug
Placebo QD or TIW
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A/B | Experimental | Not described Receives: Drug: Paricalcitol |
| Treatment group C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.
Measured: 0-24 weeks
Secondary outcomes (12)
The value of iPTH for each visit
Measured: 0-24 weeks
The change from baseline of iPTH for each visit
Measured: 0-24 weeks
The change percentage of iPTH for each visit;
Measured: 0-24 weeks
The proportion of subjects whose iPTH has been reduced by more than 30% from baseline at least 4 consecutive times;
Measured: 0-24 weeks
The change value in blood calcium from baseline;
Measured: 0-24 weeks
The change value in blood phosphorus from baseline;
Measured: 0-24 weeks
The change value in calcium-phosphorus product from baseline;
Measured: 0-24 weeks
The change value of 24-hour urine calcium from baseline;
Measured: 0-24 weeks
The change value of 24-hour urine phosphorus from baseline;
Measured: 0-24 weeks
The change value of 24-hour creatinine clearance rate from baseline;
Measured: 0-24 weeks
The change value of eGFR from baseline;
Measured: 0-24 weeks
The change value in urine calcium/creatinine ratio from baseline.
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Feb 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-center, randomized, double-blind, parallel grouping, placebo-controlled phase 3 study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994080
- Sponsor's protocol ID
- HR-PLGHC-301
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel Grouping, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Paricalcitol Soft Capsules in the Treatment of Secondary Hyperparathyroidism in Subjects With Stage 3 and Stage 4 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04994080
- Acronym / sponsor ID
- HR-PLGHC-301
- Conditions
- Secondary Hyperparathyroidism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multi-center, randomized, double-blind, parallel grouping, placebo-controlled phase 3 study
| Arm | Type | Receives |
|---|---|---|
| Treatment group A/B | Experimental | Drug: Paricalcitol |
| Treatment group C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Under care of physician at least 2 months for CKD
- Not on active Vitamin D and Calcimimetic therapy for at least 4 weeks prior
- If taking phosphate binders, on a stable regimen at least 4 weeks prior
- For entry into Pretreatment Phase:
- iPTH at least 120 pg/mL GFR of 15-60 mL/min and no dialysis expected for at least 6 months
Key exclusion criteria (13 listed)
- Subjects who had Primary hyperparathyroidism;
- Subjects with a history of acute renal failure;
- Subjects with chronic gastrointestinal disease or severe liver disease with clinical symptoms;
- Subjects with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically meaningful arrhythmia;
- Subjects with serum albumin < 30g/L, serum hemaoglobin < 85g/L, or serum transaminase higher than 2.5 times the upper limit of nomal;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParicalcitolParicalcitol QD Treatment | Drug | Treatment group A/B |
| PlaceboPlacebo QD or TIW | Drug | Treatment group C |
Primary outcome
Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.
Time frame: 0-24 weeks
12 secondary outcomes
The value of iPTH for each visit
Time frame: 0-24 weeks
The change from baseline of iPTH for each visit
Time frame: 0-24 weeks
The change percentage of iPTH for each visit;
Time frame: 0-24 weeks
The proportion of subjects whose iPTH has been reduced by more than 30% from baseline at least 4 consecutive times;
Time frame: 0-24 weeks
The change value in blood calcium from baseline;
Time frame: 0-24 weeks
The change value in blood phosphorus from baseline;
Time frame: 0-24 weeks
The change value in calcium-phosphorus product from baseline;
Time frame: 0-24 weeks
The change value of 24-hour urine calcium from baseline;
Time frame: 0-24 weeks
The change value of 24-hour urine phosphorus from baseline;
Time frame: 0-24 weeks
The change value of 24-hour creatinine clearance rate from baseline;
Time frame: 0-24 weeks
The change value of eGFR from baseline;
Time frame: 0-24 weeks
The change value in urine calcium/creatinine ratio from baseline.
Time frame: 0-24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paricalcitol in people with Secondary Hyperparathyroidism, run by Chengdu Suncadia Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yin Tong (+0518-82342973, yin.tong@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase. (time frame: 0-24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.