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NCT06597201RecruitingPhase 4

Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.

Multicenter, Prospective, Open-label, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.

Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
400 (estimated)
First submitted
9 Sept 2024
Start date
9 Aug 2024
Primary completion date
29 Jun 2025
Lead sponsor
Chengdu Qingshan Likang Pharmaceutical Co., Ltd
NCT number
NCT06597201

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 400
  • From 9 Aug 2024 to the primary completion date, 29 Jun 2025
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Within the past 3 months prior to the screening period, there has been a history of peritonitis, other infections, or inflammatory diseases, with hospitalization records;
  • The possibility of receiving a kidney transplant during the study period;
  • Patients who have used amino acid (15) peritoneal dialysate within 6 months prior to the screening period.
  • Patients with bleeding events (active gastrointestinal hemorrhage, cerebral hemorrhage), cardiovascular and cerebrovascular events (cerebral infarction, myocardial infarction, etc., and NYHA grade ≥3 of cardiac function) within 30 days before screening period.
  • Diabetic subjects with poor prior glycemic control, e.g., HbAlc \> 8%;

Other illness

  • Suffers from a malignant tumor or has a life expectancy of \<6 months;

Lab values

  • Patients with hemoglobin less than 80g/L during the screening period;
  • patients with contraindications to amino acid (15) peritoneal dialysis solutions: 1) hypersensitivity to any of the components of the product; 2) Serum urea level \>38 mmol/l; 3) Presence of uremic symptoms such as marked loss of appetite, nausea and vomiting at the time of screening; 4) Various inborn abnormalities of amino acid metabolism; 5) hepatic insufficiency (active hepatitis); active hepatitis B or C, cirrhosis, active liver disease or positive seropositivity for human immunodeficiency virus (HIV) within 6 months prior to screening; 6) Uncorrectable mechanical defects that the investigator assesses as affecting efficacy or increasing the risk of infection; 7) History of loss of peritoneal function or impairment of peritoneal function due to extensive adhesions;
  • Routine daily use of 4.25% glucose dialysis solution during the screening period;

Other

  • Patients with inadequate dialysis and screening period kt/v\<1.4;
  • In patients with active diarrhea during the screening period, as assessed by investigators, affecting nutrient absorption(Except for patients with chronic diarrhea, stool frequency \< 3 times/day);
  • Women during pregnancy or breastfeeding;
  • Other circumstances that, in the opinion of the investigator, may make participation in this study inappropriate.

Who the study is looking for

  • 18 to 75 years of age (including 18 and 75 years of age), regardless of sex;
  • Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months;
  • 25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (two occasions one week apart);
  • Blood potassium ≥ 3.5 mmol/L
  • C-reactive protein (CRP) ≤ 2 x upper limit of normal (ULN);
  • Carbon dioxide binding capacity \>18 mmol/L;
  • Subjects voluntarily sign an informed consent form in writing prior to the commencement of any procedures related to the study, fully understand the purpose and significance of the trial, and are willing to comply with the trial protocol.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People&amp;&#39;s Hospital
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BeijingChinaRecruiting
The Third Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
The Second Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
Ganzhou People&amp;#39;s Hospital
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GanzhouChinaRecruiting
Affiliated Hospital of Guangdong Medical University
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GuangdongChinaRecruiting
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaRecruiting
The Affiliated Hospital of Southwest Medical University
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LuzhouChinaRecruiting
Meishan Hospital, West China Hospital, Sichuan University (Meishan People&#39;s Hospital)
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MeishanChinaRecruiting
Jiangsu Province Hosipital
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NanjingChinaRecruiting
The Affiliated Hospital of Nanjing university Medical School
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NanjingChinaRecruiting
The First Affiliated Hospital of Guangxi Medical University
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NanningChinaRecruiting
Shanghai Sixth People&amp;amp;#39;s Hospital Affiliated to Shanghai JiaoTong University
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ShanghaiChinaRecruiting
General Hospital of Northern Theater Command
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ShenyangChinaRecruiting
Wuhan NO.1 Hospital
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WuhanChinaRecruiting
The Central Hospital of Wuhan
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WuhanChinaRecruiting
Zhongshan Hospital Xiamen University
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XiamenChinaRecruiting
The First Affiliated Hospital of Xinxiang Medical College
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XinxiangChinaRecruiting
The Second People&#39;s Hospital of Yibin City
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YibinChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.