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HyperphosphatemiaPhase 1/2NCT04440696

To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder

A Phase 1/2 study testing Lanthanum Polystyrene Sulphonate Powder and Lanthanum Carbonate 500 MG in people with Hyperphosphatemia, run by Grand Life Science (Liaoning) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study is: To evaluate the tolerance of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia with multiple doses and multiple doses； To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in hyperphosphatemia patients with… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hyperphosphatemia
What is being tested?
Lanthanum Polystyrene Sulphonate Powder and Lanthanum Carbonate 500 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteChina
Study dates
21 Oct 2020to 31 Dec 2022
Phase
Phase 1/2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Sign the informed consent before the trial, and fully understand the test content, process and possible adverse reactions;
  • 2) Able to complete the study according to the requirements of the experimental program, able to accept dietary management and unified diet during the trial;
  • 3) Regular hemodialysis was performed three times a week in the 12 weeks before screening (the total number of weeks without three times a week for special reasons should not exceed 2 weeks), and the dialysis regimen was expected to remain unchanged during the trial;
  • 4) The patient is receiving appropriate dialysis treatment, and the urea clearance index (KT /V) ≥1.2 (the KT /V value of the research center within one month before screening is valid, and the results of several measurements shall be subject to the latest measurement);
  • 5) Subjects (including partners) are willing to voluntarily use effective contraceptive measures within 6 months from the screening to the last study drug administration, as detailed contraceptive measures are shown in Appendix 4;
  • 6) Male and female subjects aged 18 to 65 years (including 18 and 65 years) with a body mass index (BMI) in the range of 18 to 35 kg/m2 (including the threshold);
Show all 31Show fewer
  • 7) In patients with end-stage renal disease hyperphosphatemia, fasting blood phosphorus ≥1.78mmol/L and ≤3.23mmol/L were measured at screening and admission.
  • Exclusion Criteria(If one of the exclusion criteria is satisfied, it is excluded):
  • 1) A history of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczema dermatitis) or known allergy to the experimental drug or similar drug;
  • 2) Patients who had severe trauma or had undergone major surgery within 6 months prior to the trial, or who planned to undergo surgery during the study period were screened;
  • 3) Blood loss > 450mL in the three months before screening;
  • 4) Clinical, radiological or laboratory evidence of active tuberculosis (TB);
  • 5) Previous kidney transplantation operations;
  • 6) A history of drug use and/or alcohol abuse in the 3 months prior to screening (14 units of alcohol consumed per week: 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine);
  • 7) Those who were receiving any vitamin D or calcium-like regimens at the time of screening and could not maintain a stable dose after admission (except those who were receiving a stable vitamin D or calcium-like regimens);
  • 8) Have dysphagia or gastrointestinal history with any influence on drug absorption, including but not limited to intestinal obstruction, macrocolon, habitual constipation (stool frequency < 1 times per week), chronic diarrhea (stool frequency ≥4 times per day), gastroparesis with nausea or vomiting and other gastrointestinal disorders and gastrointestinal surgery;
  • 9) suffer from any disease that increases the risk of gastrointestinal bleeding, such as acute erosive gastritis, acute hemorrhagic necrotizing enteritis, or active gastrointestinal ulcer;
  • 10) For poorly controlled hypertension, the systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg should be measured at rest, and the patient should be rechecked at most twice for confirmation;
  • 11) The history of acute coronary syndrome (such as myocardial infarction, unstable angina pectoris hospitalization), or percutaneous coronary intervention, or coronary artery bypass grafting in the previous 12 months was screened;Or had an arterial/venous thrombosis event, such as a cerebrovascular accident (including a history of stroke or transient ischemic attack), deep venous thrombosis and pulmonary embolism, within 12 months before screening;
  • 12) Uncontrolled severe arrhythmias, such as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia, that were not controlled by medication or other treatment in the 12 months prior to enrolment;
  • 13) Unstable and serious diseases of the digestive system, respiratory system, mental nervous system, endocrine system, blood system, malignant tumor, etc., which are not suitable for the study as judged by the study doctor;
  • 14) Screening patients with a history of acute or severe infection within the previous 1 month;
  • 15) Take phosphorus-reducing drugs, such as lanthanum carbonate, calcium carbonate, calcium acetate, aluminum hydroxide, Sveram, etc., within 14 days before administration;Drugs that may affect lanthanum ion release, such as proton pump inhibitors, H2 receptor antagonists, etc.And drugs that interact with experimental drugs, such as ciprofloxacin hydrochloride, thyroxine, lithium, etc.;Drugs containing phosphoric acid components, such as oseltamivir phosphate, sitagliptin phosphate tablets, etc.
  • 16) Those who have participated in any clinical trials of drugs or medical devices within one month before taking the study drug;
  • 17) During screening, hemoglobin ≤90g/L and albumin ≤30g/L;
  • 18) Hypercalcemia, blood calcium ≥2.52mmol/L;Hypocalcemia, blood calcium ≤1.80mmol/L (corrected blood calcium value: corrected blood calcium value mmol/L= measured calcium value mmol/L+0.02× (40g/L- measured serum albumin value g/L));
  • 19) Severe hyperparathyroidism, parathyroid hormone (PTH) >1200pg/mL;
  • 20) Female subjects with positive blood pregnancy results during the screening period or baseline period;
  • 21) HIV antigen/antibody positive;Positive antibody to Treponema pallidum and positive serological test of non-Treponema pallidum (such as rapid plasma reaction test, toluidine red unheated serum test, etc.);
  • 22) A history of heart failure as defined by the New York College of Cardiology (NYHA) as III-IV, or a left ventricular ejection fraction less than 40%;
  • 23) Subjects who have other factors considered by the investigator to be unsuitable for participating in this study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Xiaoyan Wen, MA contact

+86 18704019565

wenxiaoyan@nkbp.com

China1 site, 1 recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin

    Yanhua Ding, 18186879468, dingyanhua2003@126.com

    Recruiting

Other trials in China

About this study

Official title: To Evaluate the Tolerance, pd, and pk of Lanthanum Polystyrene-sulfonate Powder in a Phase Ib/ IIa Clinical Trial in Patients With ESRD-HD Hyperphosphatemia With Multi-center, Multi-dose, Give the Drug Multiple Time

The aim of the study is:

To evaluate the tolerance of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia with multiple doses and multiple doses； To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in hyperphosphatemia patients with end-stage renal disease on hemodialysis (ESRD-HD); To evaluate the pharmacokinetics of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia after multi-dose and multiple administration.

Being tested
Lanthanum Polystyrene Sulphonate Powder, Lanthanum Carbonate 500 MG, Placebo
Medical subject headings
Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lanthanum Polystyrene Sulphonate PowderDrug

    D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；

  • Lanthanum Carbonate 500 MGDrug

    D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；

  • PlaceboDrug

    D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；

Study groups in NCT04440696
Study groupRoleWhat they receive
group 1:dose 1.5gExperimentalThere were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
Receives: Drug: Lanthanum Polystyrene Sulphonate Powder; Drug: Lanthanum Carbonate 500 MG; Drug: Placebo
group 2:dose 3gExperimentalThere were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
Receives: Drug: Lanthanum Polystyrene Sulphonate Powder; Drug: Lanthanum Carbonate 500 MG; Drug: Placebo
group 3:dose 4.5gExperimentalThere were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
Receives: Drug: Lanthanum Polystyrene Sulphonate Powder; Drug: Lanthanum Carbonate 500 MG; Drug: Placebo
group 4:dose 6gExperimentalThere were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
Receives: Drug: Lanthanum Polystyrene Sulphonate Powder; Drug: Lanthanum Carbonate 500 MG; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood phosphate concentrations

    Measured: At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）

  2. Plasma lanthanum concentrations

    Measured: At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）

Secondary outcomes (3)

  1. 24h Urinary phosphate concentrations

    Measured: At pre-defined intervals from initial dose through final study visit（Day 1 to Day 13）

  2. Plasma PTH concentrations

    Measured: At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17）

  3. Plasma calcium concentrations

    Measured: At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17）

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2020
  2. Study start21 Oct 2020
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04440696
Sponsor's protocol ID
JBL-2019-001
Status last verified
Jul 2021
First submitted
16 Jun 2020
Last updated
28 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lanthanum Polystyrene Sulphonate Powder and Lanthanum Carbonate 500 MG in people with Hyperphosphatemia, run by Grand Life Science (Liaoning) Co., Ltd. at 1 site in China.

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 31 inclusion and 0 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Xiaoyan Wen, MA (+86 18704019565, wenxiaoyan@nkbp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood phosphate concentrations (time frame: At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04440696.

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 28 Jul 2021.

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