NCT01696279已完成2 期
A 3-part Open-label Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Compare the Efficacy, Safety and Tolerability of 8 Weeks of Treatment With Lanthanum Carbonate and Calcium Carbonate Using a Crossover Design and Investigate the Efficacy and Safety of 8 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 10 Years to <18 Years With Chronic Kidney Disease on Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 63
- 试验地点
- 22
- 主要终点
- Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)
研究概览
简要总结
The purpose of this study is to summarize the percentage of participants achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following 8 weeks of treatment with lanthanum carbonate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10 years to less than (<) 18 years of age at the time of consent.
- •Participant or parent/legally authorized representative (LAR) understand and are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol.
- •Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
- •Established chronic kidney disease (CKD), on dialysis, and requires treatment for hyperphosphatemia with a phosphate binder.
- •Serum phosphorus levels after a washout period of up to 3 weeks as follows: Age <12 years: Serum phosphorus greater than (>) 6.0 mg/dL (1.94 mmol/L); Age 12 years and older: Serum phosphorus >5.5mg/dL (1.78mmol/L).
- •Ability to provide written, signed and dated (personally or via an LAR) informed consent/and assent, as applicable, to participate in the study.
排除标准
- •Current or recurrent disease (example [eg], cardiovascular, liver, unstable and uncontrolled gastrointestinal, malignancy, or other conditions) other than CKD or end-stage renal disease that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
- •Current or relevant history of physical or psychiatric illness, any medical disorder (except for CKD or end-stage renal disease and related co-morbidities) that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- •Unable to eat semi-solid foods or on Total Enteral Alimentation.
- •Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
- •History of alcohol or other substance abuse within the last year.
- •Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment.
- •Weight and age of participant are outside of local applicable criteria for blood sample volume limits.
- •Use of another investigational product within 30 days prior to receiving the first dose of investigational product.
研究组 & 干预措施
Lanthanum Carbonate
Experimental
Participants will receive lanthanum carbonate orally at a total daily dose of 1500 mg to 3000 mg divided and mixed equally between in three meals.
干预措施: Lanthanum Carbonate (Drug)
Calcium Carbonate
Active Comparator
Participants will receive calcium carbonate orally at a total daily dose adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
干预措施: Calcium Carbonate (Drug)
结局指标
主要结局
Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)
时间窗: After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3
KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (\>=) 12 to less than (\<) 18 years to be less than or equal to (\<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter \[mmol/L\]); Children aged \>=10 years to \<12 years to be \<= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
次要结局
- Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2(Up to 19 weeks)
- Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2(Baseline, Week 8)
- Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2(Baseline, Week 8)
- Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3(Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32)
- Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)(Baseline, Week 8, Week 16 and EOS (up to 42 weeks))
- Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)(Baseline, Week 8, Week 16 and EOS (up to 42 weeks))
- Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks(Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3)
- Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3(Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32)
- Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3(Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32)
- Change From Baseline in Biochemical Bone Markers(Baseline, Week 8, Week 16 and EOS (up to 42 weeks))
- Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)(Baseline, Week 8, Week 16 and EOS (up to 42 weeks))
- Change From Baseline in Biochemical Bone Markers for Fetuin-A(Baseline, Week 8, Week 16 and EOS (up to 42 weeks))
- Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8(Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3)
- Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8(Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3)
- Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2(Baseline, Week 8)
- Change From Baseline in Height(Baseline, Week 8, Week 16, and EOS (up to 42 weeks))
- Change From Baseline in Weight(Baseline, Week 8, Week 16, and EOS (up to 42 weeks))
研究者
研究点 (22)
Loading locations...
相似试验
招募中
3 期
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo NodularisPrurigo NodularisNCT06293053Sanofi18
已完成
1 期
A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy ParticipantsHealthyNCT03649997Janssen Research & Development, LLC57
尚未招募
3 期
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes MellitusT2DM (Type 2 Diabetes Mellitus)NCT06141980Daewoong Pharmaceutical Co. LTD.134
已完成
1 期
A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248PharmacokineticNCT04617509Gesynta Pharma AB14
进行中（未招募）
3 期
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and OlderCystic FibrosisNCT06460506Vertex Pharmaceuticals Incorporated50