Phase 2
Completed N=20
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
Chronic Kidney Disease · Hyperphosphatemia
Source: ClinicalTrials.gov NCT01696279 ↗
Enrolled (actual)
20
Serious AEs
22.4%
Results posted
Jan 2020
Primary outcomePrimary: 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) — 50 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
50 | — |
| SECONDARY Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2 |
58.8; 70.6 | — |
| SECONDARY Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks |
-0.334 | — |
| SECONDARY Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8 |
-0.001 | — |
| SECONDARY Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8 |
-0.577 | — |
| SECONDARY Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2 |
-0.520; -0.467 | — |
| SECONDARY Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2 |
0.058; -0.009 | — |
| SECONDARY 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 |
-0.966; -0.669 | — |
| SECONDARY 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 |
-0.334; -0.416; -0.314; -0.316; -0.322; -0.236 | — |
| SECONDARY 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 |
-0.001; -0.045; -0.034; 0.003; -0.010; 0.049 | — |
| SECONDARY 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 |
-0.577; -0.783; -0.575; -0.362; -0.578; -0.326 | — |
| SECONDARY Change From Baseline in Biochemical Bone Markers |
-0.78; 31.86; 59.12; 8.2; 10.3; 94.0 | — |
| SECONDARY Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP) |
-1.71; 1.95; 4.65 | — |
| SECONDARY Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23) |
5130.3; -8162.4; -251.1 | — |
| SECONDARY Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH) |
-7.132; 16.273; 59.801 | — |
| SECONDARY Change From Baseline in Biochemical Bone Markers for Fetuin-A |
-0.006; 0.037; 0.039 | — |
| SECONDARY Change From Baseline in Height |
0.7; 0.6; 1.3 | — |
| SECONDARY Change From Baseline in Weight |
1.18; 1.09; 2.86 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 10 years to less 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01696279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.