Phase 3
Completed N=78
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
Chronic Kidney Disease · Hyperparathyroidism · Vitamin D Insufficiency
Source: ClinicalTrials.gov NCT01219855 ↗
Enrolled (actual)
78
Serious AEs
5.2%
Results posted
Aug 2016
Primary outcomePrimary: Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP). — 100; 100; 0; 91.7 percentage of participants — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP). |
100; 100; 0; 91.7; 7.1 | <0.0001 sig |
| PRIMARY Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population) |
-32.77; -39.32; 20.49; -20.86; 13.18 | <0.01 sig |
| SECONDARY Change From Baseline in Serum 25-hydroxyvitamin D at Week 6 |
43.25; 63.69; -0.65; 16.22; -1.89 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population |
187.64; 313.12; -2.67; 90.90; -7.22 | <0.0001 sig |
| SECONDARY Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6 |
11; 9; 2; 5; 0 | <0.05 sig |
| SECONDARY Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6 |
12; 13; 2; 5; 1 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Urinary albumin excretion of ≤3000 μg of creatinine
- Stage 3 CKD
- Plasma iPTH: > 70 pg/mL and 10 ng/mL and 0.2
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
Data sourced from ClinicalTrials.gov (NCT01219855). 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.