Advertisement

Topics

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Zemplar (Paricalcitol) in German Clinical Practice

2014-08-27 03:15:19 | BioPortfolio

Summary

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® injection and Zemplar® capsules in real-life clinical practice. In this study, Zemplar® will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with Zemplar® injection and Zemplar® capsules in long-term use.

Description

Zemplar® injection (paricalcitol i.v.) was approved in Germany in December 2004 for the prevention and treatment of secondary hyperparathyroidism in patients needing dialysis. In April 2008, Zemplar® capsules (paricalcitol for oral use) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of patients with chronic kidney disease before they reach the stage of requiring dialysis.

Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare.

Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of Zemplar® injection and Zemplar® capsules in real-life clinical practice. In this study, Zemplar® will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with Zemplar® injection and Zemplar® capsules in long-term use.

The primary aim of the study is to determine (i) the percentage of patients achieving an iPTH level within the target range of K/DQOI treatment guidelines (Chronic Kidney Disease 3: 35 - 70 pg/ml; Chronic Kidney Disease 4: 70 - 110 pg/ml; Chronic Kidney Disease 5: 150 - 300 pg/ml) during 12-month treatment with Zemplar®, (ii) the time it takes to achieve this level of response and whether it is sustained.

Secondary objectives are analysis of episodes of hypercalcemia, hyperphosphatemia and calcium phosphate product, dipstick proteinuria, health economics aspects (e.g. days off sick, hospitalizations), quality of life, adverse events, eGFR, compliance and other lab markers such as alkaline phosphatase, creatinine, 25-OH vitamin D and C-reactive protein (CRP) during the first 12 months of treatment with Zemplar®.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Renal Insufficiency

Intervention

Zemplar (paricalcitol)

Location

Site Reference ID/Investigator# 28352
Aachen
Germany
52066

Status

Recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:19-0400

Clinical Trials [1322 Associated Clinical Trials listed on BioPortfolio]

A Study of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors

The study objective is to evaluate the effect of paricalcitol capsules on albuminuria reduction in Chronic Kidney Disease (CKD) subjects with Type 2 diabetic nephropathy receiving optimal ...

Oral Paricalcitol in Kidney Transplant Recipients

This study is being done to find out whether patients who receive a kidney transplant can benefit from taking the medication paricalcitol (trade name Zemplar®) compared to kidney transpla...

Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)

The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.

Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)

The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.

Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)

The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.

PubMed Articles [2855 Associated PubMed Articles listed on BioPortfolio]

Effects of oral paricalcitol therapy on arterial stiffness and osteopontin in hypertensive patients with chronic kidney disease and secondary hyperparathyroidism.

Arterial stiffness is linked to the progression of atherosclerosis, while activation of vitamin D receptor exerts favorable cardiovascular effects in patients with renal insufficiency. In this study, ...

ACE Inhibitors and ARB in Chronic Kidney Disease: What Has to Be Considered.

Proteinuric kidney disease, especially in the early and middle stages of renal insufficiency, may be favorably affected by ACE-I/ARB. The progression of renal insufficiency is thereby slowed down and ...

Paricalcitol and Peritoneal Protein Loss in Peritoneal Dialysis: A Double-Center Study.

Peritoneal protein loss (PPL) is associated with cardiovascular disease and mortality in peritoneal dialysis (PD). Controversial results have been published about the effect of paricalcitol in PPL amo...

Outcomes Following Coronary Artery Bypass Graft Surgery in Patients with Mild Preoperative Renal Insufficiency.

Preoperative renal insufficiency is an independent predictor of mortality after coronary artery bypass graft (CABG) surgery. However, there are few reports aimed to evaluate the impact of mild preoper...

Outcome and natural course of renal dysfunction in liver transplant recipients with severely impaired kidney function prior to transplantation.

Since introduction of the MELD score in the liver allograft allocation system, renal insufficiency has emerged as an increasing problem. Here we evaluated the course of kidney function in patients wit...

Medical and Biotech [MESH] Definitions

Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. The most severe form is KIDNEY FAILURE. Renal function may deteriorate slowly (RENAL INSUFFICIENCY, CHRONIC) or precipitously (RENAL INSUFFICIENCY, ACUTE).

A condition characterized by calcification of the renal tissue itself. It is usually seen in distal RENAL TUBULAR ACIDOSIS with calcium deposition in the DISTAL KIDNEY TUBULES and the surrounding interstitium. Nephrocalcinosis causes RENAL INSUFFICIENCY.

Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)

Bis(nitrato-O)dioxouranium. A compound used in photography and the porcelain industry. It causes severe renal insufficiency and renal tubular necrosis in mammals and is an effective lymphocyte mitogen.

Condition where a primary dysfunction of either heart or kidney results in failure of the other organ (e.g., HEART FAILURE with worsening RENAL INSUFFICIENCY).

More From BioPortfolio on "Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Zemplar (Paricalcitol) in German Clinical Practice"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Dialysis
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure. Dialysis may be used for those with an acute disturba...


Searches Linking to this Trial