A Phase 4 interventional study of Zemplar (paricalcitol) in Secondary Hyperparathyroidism, Renal Insufficiency, Chronic and Parathyroid Hormone, sponsored by Abbott. Completed at 3 sites in Peru. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-31.
Sponsored by Abbott · Phase 4, Interventional, and Treatment
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH>300pg/mL) and that require dialysis at least 3 times per week.
The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.
188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's enrollment of 100 is above the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.
Browse Hyperparathyroidism, Secondary studies →Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Zemplar (paricalcitol)
Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.
Also known as: ABT-358, paricalcitol, Zemplar
The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL
The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.
Time frame: 24 weeks
Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL
Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.
Time frame: 24 Weeks
Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).
The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter \[mg/dL\]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.
Time frame: 24 Weeks
| Milestone | Paricalcitol Injection |
|---|---|
| Started | 100 |
| Completed | 88 |
| Not completed | 12 |
| Withdrew: Adverse event | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Patient noncompliance | 6 |
| Withdrew: Protocol violation | 2 |
The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.
| Percentage of participants | Paricalcitol Injection |
|---|---|
| The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL | 96.6 |
Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.
| Weeks | Paricalcitol Injection |
|---|---|
| Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL | 4 (2 to 6) |
The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter \[mg/dL\]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.
| Number of participants | Paricalcitol Injection |
|---|---|
| Hypercalcemia | 38 |
| Hyperphosphatemia | 33 |
| Elevation of Ca x P product | 31 |
Collected over Baseline through 24 weeks.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paricalcitol Injection | — | 15/100 (15%) | 47/100 (47%) |
| Event | Paricalcitol Injection |
|---|---|
| PneumoniaInfections and infestations | 5/100 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 4/100 |
| PyrexiaGeneral disorders | 2/100 |
| CellulitisInfections and infestations | 2/100 |
| Acute coronary syndromeCardiac disorders | 1/100 |
| Atrioventricular block completeCardiac disorders | 1/100 |
| BradycardiaCardiac disorders | 1/100 |
| Lower gastrointestinal haemorrhageGastrointestinal disorders | 1/100 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 1/100 |
| Humerus fractureInjury, poisoning and procedural complications | 1/100 |
| Event | Paricalcitol Injection |
|---|---|
| HypercalcemiaMetabolism and nutrition disorders | 32/100 |
| HyperphosphatemiaMetabolism and nutrition disorders | 24/100 |
| Age Continuous(years) | Paricalcitol Injection |
|---|---|
| Mean | 46 ± 12 |
| Sex: Female, Male(Participants) | Paricalcitol Injection |
|---|---|
| Female | 47 |
| Male | 53 |
| Region of Enrollment(participants) | Paricalcitol Injection |
|---|---|
| Peru | 100 |
The record gives a start of May 2009, a primary completion of Sep 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2011, 1 year 1 month after primary completion.
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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paricalcitol
Hyperparathyroidism, Secondary →