Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Neoplasms

Blood and Lymph Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Kidney Diseases

Kidney Failure, Chronic

Neoplasm Metastasis

Anemia

Hyperparathyroidism

Hyperparathyroidism, Secondary

Calcinosis

Vascular Calcification

Renal Insufficiency

Hematologic Diseases

Neoplastic Processes

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Gastrointestinal Agents

Vitamins

Cinacalcet

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Sevelamer

Calcium acetate

Aluminum hydroxide, magnesium hydroxide, drug combination

Trace Elements

Hormones

Vitamin D3

Calciferol

Control group: standard care. The iPTH target in this group is 300-540 pg/ml

Optimal CKD-MBD control: in this group the PTH target is150-300 pg/ml to be achieved with a therapeutic algorithm

Standard care. Patients allocated to this study arm will be treated with all drugs available for PTH control (at the investigator discretion) to obtain a iPTH of 300-540 pg/ml.

standard care

Optimal care. Patients allocated to this study arm will be treated with all drugs available for PTH control (at the investigator discretion - see therapeutic algorithm) to obtain a iPTH of less than 300 pg/ml.

Optimal (I. iPTH control: Zemplar®,Mimpara®; phosphorous control: Renvela®, Phoslo®, Osvaren®, Foznol®,Maalox®; calcium control: calcium and vitamin D

Antonio Bellasi, MD

Simona Urbano

Claudio Minoretti, MD

Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD) on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder (CKD-MBD)

Anemia is one of the most worrisome complications of Chronic Kidney Disease (CKD). Numerous prospective studies have repeatedly documented an increase risk of morbidity and mortality associated with lower levels of hemoglobin (Hb). Hence the international guidelines on patient care suggest the use of Erythropoietin Stimulating Agents (ESA), iron, folates supplementation for anemia correction.

However, recent randomized controlled trials (RCT) have demonstrated that hemoglobin correction to normal levels increases the risk of major cardiovascular (CV) events. Though, the reasons are still unclear, the cumulative ESA dose may at least partly explain these findings suggesting limiting ESA to the minimal dose allowed to achieve the suggested Hb targets in ESRD patients.

Among other factors, CKD-MBD has been repeatedly associated with poor more severe anemia and higher dose of ESA. However, the latest Kidney Disease: Improving Global Outcomes (KDIGO) guidelines on CKD-MBD management suggest a higher reference target for intact parathyroid hormone (iPTH) (2-9 fold the upper level of the normal range) when compared to the National Kidney Foundation (NKF) guidelines published in 2003 (150-300 pg/ml).

A few observational studies suggest a linear inverse association between intact iPTH and ESA dose even for iPTH value within the iPTH target level proposed by the KDIGO working group. Similarly, a large body of evidence supports the notion that the higher the iPTH the faster the CV system deterioration in ESRD.

Aim of the study is to test whether a tighter iPTH control to achieve a iPTH level lower than 300 pg/ml vs iPTH levels between 300-540 pg/ml is associated with a ESA dose reduction and a slower CV system deterioration in ESRD patients receiving dialysis.

STUDY DESIGN Pilot, single center, open label with blinded end point (PROBE-Prospective Randomized Open Blinded End-Point) aimed at improving patient care.

Eligible patients will be randomized (1:1) to either:

(A) Control group: standard care. The iPTH target in this group is 300-540 pg/ml (B) Optimal CKD-MBD control: in this group the iPTH target is150-300 pg/ml to be achieved with a therapeutic algorithm.

TREATMENTS

All patients will be randomized (1:1) to either:

(A) Control group: standard care. The iPTH target in this group is 300-540 pg/ml.

(B) Optimal CKD-MBD control:: in this group the iPTH target is 150-300 pg/ml to be achieved with a therapeutic algorithm:

I. iPTH control: in order to achieve the iPTH target (150-300 pg/ml), all patients will receive 400 IU/day of vitamin-25-OH-D (25OHD) and a flexible dose of any active vitamin D available in Italy (calcitriol and paricalcitol-"Zemplar®") at the maximum dose of 6 mcg/week of paricalcitol("Zemplar®")of equivalent (see existing conversion table). Patients will also receive a flexible dose of cinacalcet("Mimpara®") to a maximum dose of 90 mg/day.

II. Phosphorous control: all patients need to achieve a serum phosphorous level lower than 5.5 mg/dl. All available phosphate binders are allowed \[sevelamer("Renvela®"), calcium carbonate, calcium acetate("Phoslo®"), calcium acetate/magnesium carbonate ("Osvaren®"), lanthanum carbonate "Foznol®"). A rescue therapy with aluminum("Maalox®") is allowed for no more than 30 days.

III. Serum calcium control: the suggested target is less than 9.5 mg/dl. In case of serum calcium greater than 9.5 mg/dl the calcium and vitamin D dose should be lowered in order to lower the risk of vascular calcification deposition and progression

Optimal Anemia Treatment in End Stage Renal Disease (ERSD)

Single-center, Open-label, Randomized Study of Anemia Management Improvement in End Stage Renal Disease (ESRD) Patients With Secondary Hyperparathyroidism

Primary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a lower ESA dose use to achieve the target Hb of 10.0-11.5 g/dl

Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a better iron storage and mobilization.

Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with cardiac valves deposition and progression attenuation.

Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with arterial stiffness increase attenuation

Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a better CKD-MBD control

Amgen

Azienda Ospedaliera Sant'Anna

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Vasoconstrictor Agents

Respiratory System Agents

Antihypertensive Agents

Nitric Oxide Donors

Vasodilator Agents

Cardiotonic Agents

Central Nervous System Stimulants

Norepinephrine

Oxymetazoline

Nitroprusside

Phenylephrine

Acetylcholine

Mydriatics

Sympathomimetics

Ephedrine

Pseudoephedrine

Nasal Decongestants

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Protective Agents

Nitric Oxide

Cholinergic Agents

* Brachial artery catheter
* Acetylcholine
* Nitroprusside
* Norepinephrine
* Nitroprusside and phenylephrine

A catheter will be placed in the brachial artery by a physician on the study day.

Brachial artery catheter

Acetylcholine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Acetylcholine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.

Nitroprusside will be infused into the brachial catheter while blood flow levels in the forearm are measured. Nitroprusside will be infused at the following doses: 0.25, 0.5, 1.0, and 2.0 ug/100 ml tissue/min for 2 minutes each.

Norepinephrine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Norepinephrine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.

A single dose of nitroprusside (100 ug) will be infused through an IV; one minute later, a single dose of phenylephrine (150 ug) will be infused.

Nitroprusside and phenylephrine

Michael J Joyner, M.D.

The purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. It is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. The investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids.

The investigators are inviting women, 25-50 years old, who have not gone through menopause to participate in this study. The investigators are looking for some women with uterine fibroids and some without uterine fibroids based on ultrasound or MRI. If the patients have not had a recent ultrasound or MRI of the uterus, a physician can provide one.

Individuals cannot participate if they have high blood pressure, diabetes, or disease in the kidneys, lungs, or blood vessels. Also, individuals who smoke, have high cholesterol, or are obese (BMI is higher than 30) cannot participate. Certain medications, including high blood pressure medications, beta-blockers and anti-depressants, will also limit potential patient participation. The investigators would be happy to review medications for potential participants.

Screen Day:

One of the members of the research team will review the study and the informed consent document with the patient. The patient will have their height, weight, blood pressure, pulse and respirations measured. The patient will also complete three questionnaires. If the patient has not had an ultrasound of the uterus in the last 12 months, a physician will complete one for her.

Study Day:

The patient will need to fast overnight (no eating or drinking). The investigators will draw a blood sample and then do a series of tests on the participant's blood vessels. For some of the tests, medication will be given through an IV. The investigators will also test nerve activity in the nerve on the outer aspect of the leg.

Whole blood and serum

No DNA extraction from samples is planned.

Vascular Function and Uterine Fibroids

Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata

Blood samples will be collected to measure levels of estrogen and progesterone.

Nerve "burst" activity will be measured across 10 minutes.

An infusion of nitroprusside will be given, followed by an infusion of phenylephrine one minute later.

Mayo Clinic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optimal Anemia Treatment in End Stage Renal Disease (ERSD)	NCT02273570	Hyperparathyroi...	standard care Optimal (I. iPT...	18 Years -	Azienda Ospedaliera Sant'Anna
Vascular Function and Uterine Fibroids	NCT02123069	Leiomyoma	Brachial artery... Acetylcholine Nitroprusside Norepinephrine Nitroprusside a...	25 Years - 50 Years	Mayo Clinic

Spots Global Cancer Trial Database for vascular stiffness